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CardioNet $2.5M HIPAA Resolution Agreement Schools HIPAA Entities To Clean Up Their Acts

April 26, 2017

Remote cardiac monitoring provider CardioNet is paying $2.5 million and implementing a corrective action plan to settle potential charges of noncompliance with the Health Insurance and Portability Act (HIPAA) Privacy and Security Rules by the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) based on the impermissible disclosure of unsecured electronic protected health information (ePHI).

The first OCR HIPAA settlement involving a wireless health services provider, the CardioNet Resolution Agreement and Corrective Action Plan (Resolution Agreement) announced by OCR on April 24, 2017 clearly illustrates for all covered entities and their business associates of the substantial liability risks of failing to finalize and actually adopt, implement, administer and maintain the necessary HIPAA Privacy and Security policies and procedures required by HIPAA as well as some of the steps OCR expects to fulfill these requirements.

CardioNet Charges & Settlement

As has become increasingly common in recent years, the CardioNet settlement arose from concerns initially brought to OCR’s attention in connection with a HIPAA breach notification report. On January 10, 2012, OCR received notification from the provider of remote mobile monitoring of and rapid response to patients at risk for cardiac arrhythmias that a workforce member’s laptop with the ePHI of 1,391 individuals was stolen from a parked vehicle outside of the employee’s home. CardioNet subsequently notified OCR of a second breach of ePHI 2,219 individuals, respectively.

Likewise, the HIPAA breaches uncovered by OCR in the course of investigating these CardioNet breaches occur in the operations of many other covered entities. According to the OCR’s investigation in response to these breach reports revealed a series of continuing compliance concerns, including:

CardioNet failed to conduct an accurate and thorough risk analysis to assess the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI and failed to plan for and implement security measures sufficient to reduce those risks and vulnerabilities;
CardioNet’s policies and procedures implementing the standards of the HIPAA Security Rule were in draft form and had not been implemented;
CardioNet was unable to produce any final policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices;
CardioNet failed to implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain electronic protected health information into and out of its facilities, the encryption of such media, and the movement of these items within its facilities until March 2015; and
CardioNet failed to safeguard against the impermissible disclosure of protected health information by its employees, thereby permitting access to that information by an unauthorized individual, and failed to take sufficient steps to immediately correct the disclosure.

To resolve these OCR charges, CardioNet agrees in the Resolution Agreement to pay $2.5 million to OCR and implement a corrective action plan. Among other things, the corrective action plan requires CardioNet to complete the following actions to the satisfaction of OCR:

Prepare a current, comprehensive and thorough Risk Analysis of security risks and vulnerabilities that incorporates its current facility or facilities and the electronic equipment, data systems, and applications controlled, currently administered or owned by CardioNet, that contain, store, transmit, or receive electronic protected health information (“ePHI”) and update that Risk Analysis annually or more frequently, if appropriate in response to environmental or operational changes affecting the security of ePHI.
Assess whether its existing security measures are sufficient to protect its ePHI and revise its Risk Management Plan, Policies and Procedures, and training materials and implement additional security measures, as needed.
Develop and implement an organization-wide Risk Management Plan to address and mitigate any security risks and vulnerabilities found in the Risk Analysis as required by the Risk Management Plan.
Review and, to the extent necessary, revise, its current Security Rule Policies and Procedures (“Policies and Procedures”) based on the findings of the Risk Analysis and the implementation of the Risk Management Plan to comply with the HIPAA Security Rule.
Provide certification to OCR that all laptops, flashdrives, SD cards, and other portable media devices are encrypted, together with a description of the encryption methods used (“Certification”).
Review, revise its HIPAA Security training to include a focus on security, encryption, and handling of mobile devices and out-of-office transmissions and other policies and practices require to address the issues identified in the Risk Assessment and otherwise comply with the Risk Management Plan and HIPAA train its workforce on these policies and practices.
Investigate all potential violations of its HIPAA policies and procedures and notify OCR in writing within 30 days of any violation.
Submit annual reports to OCR, which must be signed by an owner or officer of CardioNet attesting that he or she has reviewed the annual report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.
Maintain for inspection and copying, and provide to OCR, upon request, all documents and records relating to compliance with the corrective action plan for six years.

Implications For Covered Entities & Business Associates

The CardioNet Resolution Agreement contains numerous lessons for other Covered entities and their business associates, including but not limited to the following.

Like many previous resolution agreements announced by OCR, the Resolution Agreement reiterates the responsibility of covered entities and business associates to properly secure their ePHI and that as part of this process, OCR expects all laptop computers and other mobile devices containing or with access to ePHI be properly encrypted and secured.
It also reminds covered entities and their business associates to be prepared for, and expect an audit from OCR when OCR receives a report that their organization experienced a large breach of unsecured ePHI.
The Resolution Agreement’s highlighting of the draft status of CardioNet’s privacy and security policies also reflects OCR expects covered entities to actually final policies, procedures and training in place for maintaining compliance with HIPAA.
The discussion and requirements in the Corrective Action Plan relating to requirements to conduct comprehensive risk assessments at least annually and in response to other events, and to update policies and procedures in response to findings of these risk assessments also drives home the importance of conducting timely, documented risk analyses of the security of their ePHI, taking prompt action to address known risks and periodically updating the risk assessment and the associated privacy and security policies and procedures in response to the findings of the risk assessment and other changing events.
The requirement in the Resolution Agreement of leadership attestation and certification on the required annual report reflects OCR’s expectation that leadership within covered entities and business associates will make HIPAA compliance a priority and will take appropriate action to oversee compliance.
Finally, the $2.5 million settlement payment required by the Resolution Agreement and its implementation against CardiNet makes clear that OCR remains serious about HIPAA enforcement.

Of course, covered entities and business associates need to keep in mind that that actions and inactions that create HIPAA liability risks also carry many other potential legal and business risks. For instance, since PHI records and data involved in such breaches usually incorporates Social Security Numbers, credit card or other debt or payment records or other personal consumer information, and other legally sensitive data, covered entities and business associates generally also may face investigation, notification and other responsibilities and liabilities under confidentiality, privacy or data security rules of the Fair and Accurate Credit Transaction Act (FACTA), the Internal Revenue Code, the Social Security Act, state identity theft, data security, medical confidentiality, privacy and ethics, insurance, consumer privacy, common law or other state privacy claims and a host of other federal or state laws. Depending on the nature of the covered entity or its business associates, the breach or other privacy event also may trigger fiduciary liability exposures for health plan fiduciaries in the case of a health plan, professional ethics or licensing investigations or actions against health care providers, insurance companies, administrative service providers or brokers, shareholder or other investor actions, employment or vendor termination or disputes and a host of other indirect legal consequences.

Beyond, and regardless of the technical legal defensibility of its actions under these and other laws, however, the most material and often most intractable consequences of a HIPAA or other data or other privacy breach report or public accusation, investigation, admission also typically are the most inevitable:

The intangible, but critical loss of trust and reputation covered entities and business associates inevitably incur among their patients, participants, business partners, investors and the community; and
The substantial financial expenses and administrative and operational disruptions of investigating, defending the actions of the organization and implementation of post-event corrective actions following a data or other privacy breach, audit, investigation, or charge.

In light of these risks, covered entities business associates and their management should use the experiences of CardioNet and other covered entities or business associates caught violating HIPAA or other privacy and security standards to reduce their HIPAA and other privacy and data security exposures. Management of covered entities and their business associates should take steps to ensure that their organizations policies, practices and procedures currently are up-to-date, appropriately administered and monitored, and properly documented. Management should ensure that their organizations carefully evaluate and strengthen as necessary their current HIPAA risk assessments, policies, practices, record keeping and retention and training in light of these and other reports as they are announced in a well-documented manner. The focus of these activities should be both to maintain compliance and position their organizations efficiently and effectively to respond to and defend their actions against a data breach, investigation, audit or accusation of a HIPAA or other privacy or security rule violation with a minimum of liability, cost and reputational and operational damages.

As the conduct of these activities generally will involve the collection and analysis of legally sensitive matters, most covered entities and business associates will want to involve legal counsel experienced with these matters and utilize appropriate procedures to be able to use and assert attorney-client privilege and other evidentiary privileges to mitigate risks associated with these processes. To help plan for and mitigate foreseeable expenses of investigating, responding to or mitigating a known, suspected or asserted breach or other privacy event, most covered entities and business associates also will want to consider the advisability of tightening privacy and data security standards, notification, cooperation and indemnification protections in contracts between covered entities and business associates, acquiring or expanding data breach or other liability coverage, or other options for mitigating the financial costs of responding to a breach notification, investigation or enforcement action.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to manage and defend compliance, public policy, regulatory, staffing and other operations and risk management concerns. A core focus of this work includes work to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; dealings with JCHO and other accreditation and quality organizations; investigation and defense of private litigation and other federal and state health care industry investigations and enforcement; insurance or other liability management and allocation; process and product development; managed care, physician and other staffing, business associate and other contracting; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.

In the course of this work, Ms. Stamer has accumulated extensive experience helping health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training, board, medical staff and other governance; compliance and internal controls; strategic planning, process and quality improvement; change management; assess, deter, investigate and address staffing, quality, compliance and other performance; meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other data security, privacy and breach laws. Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns.

In connection with this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.

Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

The American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other “nonpar,” insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional organizations.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.

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©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.

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Posted by Cynthia Marcotte Stamer

Learn From Children’s New $3.2M+ HIPAA CMP For “Knowing” Violation of HIPAA Security Rules

February 2, 2017

The just-announced $3.2 million Health Insurance Portability & Accountability Act (HIPAA) Civil Monetary Penalty (CMP) that Children’s Medical Center of Dallas (Children’s) recently paid for failing to adequately secure electronic protected health information (ePHI) and correct other HIPAA compliance deficiencies demonstrates the risks healthcare providers, health plans and insurers, healthcare clearinghouses and their business associates (“Covered Entities”) run by failing to take appropriate, well-documented actions to timely to secure ePHI on systems and mobile devices or comply with other HIPAA Privacy or Security requirements.

The Department of Health & Human Services (HHS) Office of Civil Rights (OCR) imposed the $3,217,000.00 Civil Monetary Penalty (CMP) under a January 18, 2017 Final Determination based upon findings that Children’s for years knowingly violated HIPAA by failing to encrypt or otherwise properly secure ePHI on laptops and other mobile devices and failing to comply with many other HIPAA requirements. OCR originally notified Children’s of its intention to impose the CMP based on findings of widespread violations by Children’s of HIPAA in a September 30, 2016 Notice of Proposed Determination (Proposed Determination) that OCR sent to Children’s President of System Clinical Operations, David Berry. Although the Proposed Determination included instructions for requesting a hearing on the Proposed Determination, Children’s paid the CMP rather than exercising these hearing rights.

Breach Notice Investigation Reveals Children’s Failed For Years To Secure ePHI on Mobile Devices Despite Repeated Warnings

According to the Proposed Determination, OCR uncovered widespread HIPAA violations by Children’s while investigating the HIPAA compliance of the Dallas-based pediatric health and hospital system in response to two separate notices of large breaches of ePHI that Children’s filed with OCR in response to the HIPAA Breach Notification Rule. Under the Breach Notification Rule, Covered Entities generally must provide notice of any breach of unsecured ePHI involving more than 500 individuals with OCR, subjects of the breached ePHI and the media within 60 days of receiving notice of the breach. In contrast, for breaches of unsecured ePHI involving fewer than 500 individuals, Covered Entities generally must notify subjects of the breached ePHI within 60 days, but can delay notification to OCR until filing a consolidated annual report of small breaches of ePHI.

The two breach notifications that triggered the OCR investigation leading to the CMP both involved losses of mobile devices containing ePHI that Children’s filed with OCR.

The first breach report, filed on January 18, 2010, notified OCR of the loss at the Dallas/Fort Worth International Airport on November 19, 2009 of an unencrypted, non-password protected BlackBerry device containing the ePHI of approximately 3,800 individuals.

The second reported breach report filed on July 5, 2013, reported the theft of an unencrypted laptop with the ePHI of 2,462 individuals from its premises sometime between April 4 and April 9, 2013. The OCR investigation found that although Children’s implemented some physical safeguards to the operating room storage area (e.g., badge access was required, and a security camera was present at one of the entrances), it also provided access to the area to staff who were not authorized to access ePHI. Children’s janitorial staff had unrestricted access to the area where the laptop was stored but did not provide encryption to protect the ePHI on the laptop from access by such unauthorized persons. Children’s internal investigation concluded that the laptop was probably stolen by a member of the janitorial staff.

In the course of investigating these two reported breaches, OCR took note that Children’s previously reported a small breach of unsecured ePHI on an unencrypted mobile device. In a letter dated August 22, 2011, from Children’s Vice President of Compliance and Internal Audit and Chief Compliance Officer Ron Skillens to OCR Equal Opportunity Specialist Jamie Sorley, Mr. Skillens stated that a Children’s workforce member (an unidentified medical resident) lost an iPod device in December 2010. The iPod had been synched to the resident’s Children’s email account, which resulted in the ePHI of at least 22 individuals being placed on the device. The ePHI on the iPod was not encrypted. The loss of the iPod resulted in the impermissible disclosure of ePHI by the medical resident. OCR concluded the ePHI of 22 individuals was impermissibly disclosed, because the workforce member and agent of Children’s provided access to any unauthorized person who discovered the device.

OCR found that the breaches resulted from Children’s violation of the HIPAA Security Rule by failing to encrypt laptops and other mobile devices or and implement other appropriate safeguards for the protection of ePHI on mobile devices;
Failing to appropriately document its decision to not implement encryption on mobile devices and any applicable rationale behind a decision to use alternative security measures to encryption; and
Failing to implement security measures that were an equivalent alternative to the security protection available from encryption solutions.

The Proposed Determination also reports that the OCR ’s investigation revealed that Children repeatedly over several years knowingly failed to implement and administer proper encryption and other safeguards on laptops and other mobile devices containing ePHI despite actual knowledge of the unaddressed risks to unencrypted ePHI in violation of the HIPAA Security Rule dating back to at least 2007. The Proposed Determination notes, for instance, that:

A Security Gap Analysis and Assessment conducted for Children’s December 2006-February 2007 by Strategic Management Systems, Inc. (SMS) (SMS Gap Analysis) identified the absence of risk management as a major finding and recommended that Children’s implement encryption to avoid loss of PHI on stolen or lost laptops.
A separate PricewaterhouseCoopers (PwC) analysis of threats and vulnerabilities to certain ePHI (PwC Analysis) conducted in August, 2008 for Children’s determined that encryption was necessary and appropriate. The PwC Analysis also determined that a mechanism was not in place to protect data on a laptop, workstation, mobile device, or USB thumb drive if the device was lost or stolen and identified the loss of data at rest through unsecured mobile devices as being “high” risk. PwC identified data encryption as a “high priority” item and recommended that Children’s implement data encryption in the fourth quarter of 2008.
Furthermore, in September 2012, the HHS Office of the Inspector General (OIG) issued the findings from its audit of Children’s that focused on information technology controls for devices such as smartphones and USB drives. Among other things, the report, entitled “Universal Serial Bus Control Weaknesses Found at Children’s Medical Center,” found that Children’s had insufficient controls to prevent data from being written onto unauthorized and unencrypted USB devices and that “without sufficient USB controls, there was a risk that ePHI could have been written onto an unauthorized/unencrypted USB device and taken out of the hospital, resulting in a data breach.” A copy of this report was provided to Mr. Skillens.
Despite the prior breach notifications and warnings from the SMS Gap Analysis, the PwC Analysis and the OIG audit report, Children’s failed to take the necessary steps to encrypt and otherwise safeguard its ePHI on mobile devices. Children’s still had not implemented encryption on all devices as of April 9, 2013 even though appropriate commercial encryption products were available to achieve encryption of laptops, workstations, mobile devices, and USB thumb drives in use by Children’s staff by, at least, the time of the PwC Analysis in 2008. Furthermore, while leaving these deficiencies unresolved, the Proposed Determination notes that Children’s issued unencrypted BlackBerry devices to nurses beginning in 2007 and allowed its workforce members to continue using unencrypted laptops and other mobile devices until at least April 9, 2013 despite the findings of SMS and PwC and Children’s actual knowledge about the risk of maintaining unencrypted ePHI on its devices.

Based on this evidence, OCR concluded that Children’s had “actual knowledge” of the unaddressed threats to ePHI as early as March 2007 and at least one year prior to the reported security incidents. Furthermore, OCR also found that Children’s additionally violated HIPAA by failing to implement sufficient policies and procedures governing the receipt and removal of hardware and electronic media that contain ePHI into and out of its facility, and the movement of these items within the facility prior to at least November 9, 2012. Prior to November 2012, Children’s information technology (IT) assets were inventoried and managed separately from the inventory of devices used within its Biomedical Department. Children’s IT asset policies did not apply to devices that accessed or stored ePHI that were managed by the Biomedical Department. Consequently, Children’s was unable to identify all devices to which the device and media control policy should apply prior to completing a full-scope inventory to identify all information systems containing ePHI in November 9, 2012. As Children’s did not conduct a complete inventory to identify all devices to which its IT asset policies apply to ensure that all devices were covered by its device and media control policies, the Proposed Determination concluded Children’s was out of compliance with the Security Rule at 45 C.P.R. § 164.310(d)(l).

After OCR’s investigation indicated widespread Privacy and Security Rule noncompliance by Children’s, the Proposed Determination states that OCR attempted to negotiate a resolution with Children’s through its informal resolution agreement process from approximately November 6, 2015, to August 30, 2016. When these efforts failed, OCR issued a May 10,2016 Letter of Opportunity that formally informed Children’s that since OCR had been unable to resolve its findings that Children’s violated the Privacy and Security Rules by informal means, OCR was informing Children’s of the preliminary indications of non-compliance and providing Children’s with an opportunity to submit written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 45 C.F.R. § 160.410 for OCR’s consideration in making a determination of a CMP pursuant to 45 C.F.R. § 160.404. The letter stated that Children’s could also submit written evidence to support a waiver of a CMP for the indicated areas of non-compliance. Each of Children’s indicated acts of noncompliance and the potential CMP for them were described in the letter. The letter was delivered to Children’s and received by Children’s agent on May 12, 2016.

Children’s responded to OCR’s letter on or about June 9, 2016. The Proposed Determination states that OCR determined that the information and arguments submitted by Children’s in its June 9, 2016 letter did not support an affirmative defense pursuant to 45 C.F.R. § 160.410 or a waiver of the CMP pursuant to 45 C.F.R. § 160.412. Accordingly, OCR notified Children’s in its September 30, 2016 Proposed Determination of OCR’s intent to implement the $3,217,000.00 CMP and procedures for appealing this planned CMP assessment. When Children’s did not file an appeal, OCR issued the Final Determination assessing the CMP. OCR reports that Children now has paid the $3,217,000.00 CMP.

Important Lessons For Other Covered Entities & Their Leaders

The Children’s CMP and underlying circumstances provide many key lessons for other Covered Entities. Obviously, the Final Decision drives home the importance of:

Proper encryption and other security and access controls of devices and systems containing ePHI; and
Proper documentation of risk assessments, audits, breach investigations and other events, compliance analysis and conclusions taken in response, and corrective actions selected and implemented in response to these events.

Beyond the importance of documented compliance with encryption and other requirements, the Children’s CMP and its associated Proposed Determination and Final Determinations also illustrate the importance of proper behavior in response to a known or suspected breach. The Proposed Determination and Final Determination make clear that beyond the breaches uncovered in the course of the investigation, OCR’s decision to implement the CMP was influenced by, among other things:

The recurrent disregard and failure by Children to act to address the HIPAA security violations over a period of years despite both repeated notifications of its noncompliance and actual breaches resulting from these compliance deficiencies; and
The failure of Children’s to cooperate with OCR to reach a voluntary resolution agreement which might have allowed Children to resolve its liability for the breaches OCR found by paying a potentially smaller settlement payment and implementing corrective actions to OCR’s satisfaction.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, the author of this uProposed Determinationate is widely known for her 28 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps these and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s includes nearly 30 years’ of work with a diverse range of health industry clients on an extensive range of matters.

Ms. Stamer has worked closely with health industry, managed care and insurance and other businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of staffing, human resources and workforce performance management, internal controls and regulatory compliance, change management and other performance and operations management and compliance. She supports her clients both on a real-time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns including policy design, drafting, administration and training; business associate and other contracting; risk assessments, audits and other risk prevention and mitigation; investigation, reporting, mitigation and resolution of known or suspected breaches, violations or other incidents; and defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others. Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy and governmental and regulatory affairs experience, Ms. Stamer also is widely recognized for regulatory and policy work, advocacy and outreach on healthcare, education, aging, disability, savings and retirement, workforce, ethics, and other policies. Throughout her adult life and career, Ms. Stamer has provided thought leadership; policy and program design, statutory and regulatory development design and analysis; drafted legislation, proposed regulations and other guidance, position statements and briefs, comments and other critical policy documents; advised, assisted and represented health care providers, health plans and insurers, employers, professional. and trade associations, community and government leaders and others on health care, health, pension and retirement, workers’ compensation, Social Security and other benefit, insurance and financial services, tax, workforce, aging and disability, immigration, privacy and data security and a host of other international and domestic federal, state and local public policy and regulatory reforms through her involvement and participation in numerous client engagements, founder and Executive Director of the Coalition for Responsible Health Policy and its PROJECT COPE: the Coalition on Patient Empowerment, adviser to the National Physicians Congress for Healthcare Policy, leadership involvement with the US-Mexico Chamber of Commerce, the Texas Association of Business, the ABA JCEB, Health Law, RPTE, Tax, Labor, TIPS, International Life Sciences, and other Sections and Committees, SHRM Governmental Affairs Committee and a host of other involvements and activities.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

Beyond her extensive involvement advising and representing clients on privacy and data security concerns and other health industry matters, Ms. Stamer also has served for several years as a scrivener for the ABA JCEB’s meeting with OCR, the Chair of the Southern California ISSA Health Care Privacy & Security Summit, and an editorial advisory board member, author, program chair or steering committee member, and faculties for a multitude of other programs and publications regarding privacy, data security, technology and other compliance, risk management and operational concerns in the health care, health and other insurance, employee benefits and human resources, retail, financial services and other arenas.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

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Posted by Cynthia Marcotte Stamer

$2.7M OCR Settlement Warns HIPAA Covered Entities To Clean Up Compliance

October 28, 2016

A new settlement agreement requiring Oregon Health & Science University (OHSU) to pay $2.7 million and implement a comprehensive three-year corrective action plan to resolve charges it violated the Health Insurance Portability & Accountability Act Privacy & Security Rules (HIPAA) sends a clear warning to other health care providers, health plans, healthcare clearinghouses (Covered Entities) and their business associates to encrypt devices with protected health information (PHI), have signed HIPAA-compliant business associate agreement in place before letting them access PHI and otherwise keep your HIPAA enterprise risk assessment and compliance up-to-date.

OHSU Charges

The OHSU settlement announced September 23 settled Department of Health & Human Services Office of Civil Rights (OCR) charges of multiple, long-standing, systematic HIPAA violations by OHSU uncovered by OCR as a result of investigations initiated in response to three reports of large-scale breaches of electronic protected health information (ePHI) made by OHSU.

OCR opened its HIPAA investigations at OHSU after the large public academic health center and research university centered in Portland, Oregon, submitted three HIPAA breach reports affecting thousands of individuals, including two reports involving unencrypted laptops and another large breach involving a stolen unencrypted thumb drive:

On March 23, 2013, HHS received notification from OHSU regarding a breach of its unsecured electronic protected health information (“ePHI”) resulting from a stolen laptop computer;
On July 28, 2013, HHS received notification from OHSU regarding a breach of its ePHI resulting from storing ePHI at an internet-based service provider without a business associate agreement; and.
On May I, 2013, and on November 8, 2013, HHS notified OHSU of its investigations of these breach incidents, respectively, regarding OHSU’s compliance with the HIPAA Rules.

These incidents each garnered significant local and national press coverage. OCR’s investigation uncovered evidence of widespread vulnerabilities within OHSU’s HIPAA compliance program, including the storage of the ePHI of more than 3,000 individuals on a cloud-based server without a business associate agreement. OCR found significant risk of harm to 1,361 of these individuals due to the sensitive nature of their diagnoses.

OCR found the reported breaches resulted from widespread, long-term, systematic and unresolved HIPAA violations by OHSU that OCR attributed to an inadequate commitment to and oversight of HIPAA compliance by OHSU C-level management which lead OHSU to fail to appropriately monitor and maintain its ongoing compliance and to assess and address changes in its enterprise-wide risk and compliance obligations on an ongoing basis. OHSU performed risk analyses in 2003, 2005, 2006, 2008, 2010, and 2013, but OCR’s investigation found that these analyses did not cover all ePHI in OHSU’s enterprise, as required by the Security Rule. While the analyses identified vulnerabilities and risks to ePHI located in many areas of the organization, OHSU did not act in a timely manner to implement measures to address these documented risks and vulnerabilities to a reasonable and appropriate level. OHSU also lacked policies and procedures to prevent, detect, contain, and correct security violations and failed to implement a mechanism to encrypt and decrypt ePHI or an equivalent alternative measure for ePHI maintained on its workstations, despite having identified this lack of encryption as a risk.

Based on these findings, OCR concluded that while OHSU initially adopted HIPAA Policies, the reported breaches were the result of a series of widespread and ongoing breaches of HIPAA resulted including the following:

From January 5, 2011, until July 3, 2013, OHSU disclosed the ePHI of 3,044 individuals in violation of Privacy Rules §§160.103 and 164.502(a) when workforce members disclosed the ePHI to a third-party internet-based service provider without obtaining a business associate agreement or other satisfactory assurance that the internet-based service provider would safeguard the ePHI;
From January 5, 2011 until July 3, 2013 OHSU failed to obtain a business associate agreement from an internet-based service provider that was storing ePHI on its behalf as a business associate as required by 45 C.F.R. § 164.308(b);
From January 5, 2011 until July 3, 2013 OHSU failed to implement policies and procedures to prevent, detect, contain, and correct security violations as required under Privacy Rule § 164.308(a)(1)(i);
From July 12, 2010 to present, OHSU failed to implement a mechanism to encrypt and decrypt ePHI or an equivalent alternative measure for all ePHI maintained in OHSU’s enterprise as required by Privacy Rules §§ 164.312(a)(2)(iv) and 164.306(d)(3)); and
From May 29, 2013 until July 3, 2013, OHSU failed to implement policies and procedures to address security incidents in violation of Privacy Rule § 164.308(a)(6)(i).

According to statements made by OCR Director Jocelyn Samuels in OCR’s announcement of the OHSU Settlement, the breaches should not have happened. “From well-publicized large-scale breaches and findings in their own risk analyses, OHSU had every opportunity to address security management processes that were insufficient,” said OCR Director Jocelyn Samuels. OCR’s announcement also signals that OCR views inadequate commitment and oversight by OHSU’s senior management to have played a key role in the creation and perpetuation of the OHSU violations. It quotes OCR Director Jocelyn Samuels as stating, “This settlement underscores the importance of leadership engagement and why it is so critical for the C-suite to take HIPAA compliance seriously.”

To resolve the HIPAA charges, the OHSU Settlement requires OHSU to pay OCR $2,700,000 as well as take a long series of corrective actions detailed in the Corrective Action Plan incorporated into the Settlement Agreement. The requirements of the Corrective Action Plan both seek to address the specific weaknesses that lead to the breaches of unsecured ePHI reported by OHSU in its breach notifications as well as the broader deficiencies in OHSU’s overall HIPAA compliance practice by requiring among other things that OHSU:

Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI at all OHSU facilities and on all systems, networks, and devices that create, receive, maintain, or transmit ePHI;.
Develop and present to OCR for approval a comprehensive written risk managementh plan that explains OHSU’s strategy for implementing security measures sufficient to reduce the risks and vulnerabilities identified in the risk analysis to a reasonable and appropriate level based on OHSU’s circumstances as well as a comprehensive, enterprise-wide plan to implement effective oversight of OHSU workforce members to ensure their adherence to HIPAA Rules and OHSU’s internal privacy and security policies and procedures with specific timelines for their expected completion and compensating controls identified in the interim to safeguard OHSU’s ePHI;
Implement and administer the written risk management plan and other safeguards as approved by OCR;
Provide updates to OCR about OHSU’s implementation of required encryption including a Mobile Device Management (MDM) solution that ensures all OHSU- owned and personally-owned mobile devices (tablets, smart phones, and other mobile devices) that access ePHI on OHSU’s secure network are encrypted other than mobile devices for which OHSU has granted exceptions based on documented evidence of the implementation of alternative reasonable compensating controls to protect the ePHI on such devices;
Report to OCR on OHSU’s efforts to a solution to enforce encryption of ePHI on OHSU-owned and personally-owned devices (laptops, desktops, and medical equipment) connecting to OHSU’s secure wired and wireless networks except for any devices for which OHSU has granted exceptions to the encryption requirement;
Report to OCR about its implementation of policies that prohibit the transfer of data containing ePHI from OHSU-owned and personally-owned devices to unencrypted removable storage devices (USB drives and portable hard drives) and implementation of a technical solution that enforces the policies prohibiting transfers of this type when attached to the OHSU secure network, except for any removable storage devices for which OHSU has granted exceptions based on documented evidence of reasonable compensating controls that have been implemented to protect the ePHI on such devices;
Send a communication to all members of the OHSU community describing its commitment to enterprise encryption;
Prepare to the satisfaction of OCR security awareness training materials needed to implement its security management processing including specific privacy and security awareness related to a) use of internet-based information storage services; b) disclosures to third-party entities that require a business associate agreement or other reasonable assurance in place to ensure that the business associate will safeguard the protected health information (PHI) and/or ePHI; c) regarding managers, effective oversight of workforce members’ uses and disclosures of PHI, including ePHI, to ensure the workforce members’ compliance with the Privacy and Security Rules and OHSU’s internal policies and procedures; d) security incident reporting; and e) password management;
Initially train all workforce members with access to PHI and/or ePHI with 120 days of OCR’s approval of the training and thereafter ensure that new workforce members are trained with 15 days of hire and that all workforce members subsequently continue to receive training on an ongoing basis
Review the security awareness training materials annually, and, where appropriate, update the training to reflect changes in Federal law or HHS guidance, any issues discovered during audits or reviews, and any other relevant developments.
Management oversight and reporting to OCR concerning OHSU’s implementation and compliance with the Corrective Action Plan and HIPAA.

OHSU Lessons For Other Covered Entities & Business Associates & Their Management

The OHSU Settlement Agreement gives notice to all Covered Entities and business associates and their C-level management that OCR expects these organizations and their top management to get serious about HIPAA compliance. The OHSU Settlement shows Covered Entities and their business associates that they must constantly reassess their required HIPAA Privacy and Security policies and safeguards as well as risks to PHI and ePHI. In the event of a breach or audit, these organization’s leadership needs to ensure their organization can show both a strong commitment to HIPAA compliance and their actions to ensure their organization appropriately monitors events and developments that could impact the adequacy of their existing measures and timely update their systems and security, policies, procedures, training and other relevant safeguards.

The Settlement also makes clear that Covered Entities and their business associates should ensure that their organization possesses a well-documented current enterprise-wide risk assessment, as well as has in place and is administering as necessary to maintain the currency and adequacy of its risk assessment strong practices for conducting documented evaluations of their own HIPAA security, policies, practices, audits and investigations and other procedures necessary to comply with HIPAA, taking into account recent OCR guidance, its initiation of its Phase II audit program, the insights offered by OCR’s ever growing list of enforcement actions and compliance tools, as well as changes in systems, documentation, software, equipment or other occurrences within the operations of the Covered Entity or business associate’s operations that could impact the currency and adequacy of its risk assessment or otherwise raise compliance risks.

In this respect, Covered Entities and business associates are encouraged to take special note of the advisability of specifically reviewing and updating their HIPAA policies, practices, business associate agreements, training, oversight and documentation to in response to the guidance and insight that OCR provides, including:;

HIPAA Settlement Illustrates The Importance Of Reviewing And Updating, As Necessary, Business Associate Agreements (September 23, 2016); Business Associate’s Failure to Safeguard Nursing Home Residents’ PHI Leads to $650,000 HIPAA Settlement (June 29, 2016);
Clarification of Permissible Fees for HIPAA Right of Access – Flat Rate Option Up to $6.50 is Not a Cap on All Fees for Copies of PHI (May 23, 2016)
Guidance On HIPAA & Cloud Computing released October 6, 2016, which provides guidance for Covered Entities and business associates about contracting and other procedures that HIPAA-regulated Covered Entities and their business associates should implement when contracting for and using Cloud Computing Services;
Joint Guidance published October 21, 2016 by the Federal Trade Commission and OCR reminding Covered Entities and their business associates of the need to ensure that in addition to fulfilling the technical content requirements of HIPAA, their HIPAA authorizations, privacy practices notices and other HIPAA notices and communications are written and presented in plan language, include required specific terms and descriptions and in a manner that does not mislead individuals about their rights or about what is happening with their PHI. Furthermore, where Covered Entities and their business associates contemplate that businesses associates may request that individuals sign HIPAA authorizations, Covered Entities and their business associates should the Covered Entity and business associate have in place a current, signed HIPAA-compliant business associate agreement that expressly authorizes the business associate to request the HIPAA authorization in light of statements in the Joint Guidance indicating that OCR views the Privacy Rules as prohibiting a business associate from asking a consumer to sign a HIPAA authorization unless its business associate contract expressly permits the business associate to do so; and
Other OCR enforcement actions, tools and guidance. See, e.g. All Covered Entities Should Learn Lessons From Mississippi Medical Center’s $2.75 Million HIPAA Resolution Agreement; Providers, Health Plans Should Confirm Copy Charges Comply With New OCR HIPAA Guidance; $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use; Addressing Gaps in Cybersecurity: OCR Releases Crosswalk Between HIPAA Security Rule and NIST Cybersecurity Framework; HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework.

Employer and other health plan sponsors, health plan fiduciaries and business associates, and their service providers also generally will want to consider their responsibilities to provide and enforce employer certifications, as well as the fiduciary obligations health plan fiduciaries under the fiduciary responsibility rules of the Employee Retirement Income Security Act (ERISA). Among other things, wrongful disclosure of PHI to a sponsoring employer or others could violate HIPAA or other plan terms. Furthermore, Department of Labor officials have indicated stated that a fiduciary’s general fiduciary responsibilities can apply to the protection and administration of PHI and other health plan information as well as create a duty by a responsible fiduciary to prudently investigate and take steps to address breaches or other potential concerns that place PHI at risk. See, HIPAA Settlement Warns Health Plans, Sponsoring Employers & Business Associates To Manage HIPAA Risks.

Furthermore, as breaches of PHI and other violations of HIPAA also frequently give rise to responsibilities or risks under a broad range of other federal and state laws medical and financial privacy and data security, Medicare and other terms of federal program participation, medical credentialing, licensure and ethics, insurance and Employee Retirement Income Security Act fiduciary responsibilities in the case of health plans, contractual, tort and other exposures, Covered Entities and their business associates also generally are best served to take into account these other responsibilities and exposures in conjunction with the design and administration of their HIPAA compliance and risk management policies and practices.

Covered Entities and their business associates also should seek advice from legal counsel regarding the adequacy of their compliance, investigatory, training, management oversight, training, reporting, documentation, document retention and other processes and procedures that could reduce risks of HIPAA violations and position the organization to effectively and more efficiently respond to a potential breach, audit, investigation or enforcement action and mitigate the costs and potential liability exposures that increasingly attends these events. In addition, given the typically high financial, operational and legal costs typically incurred to conduct investigations, report and redress breaches, and respond to OCR audits or investigations, much less make any payments and implement any corrective actions required to settle OCR changes, most Covered Entities and their business associations will want to consider the advisability and adequacy of insurance and other sources of funding or indemnification for the often substantial costs that often attend a HIPAA breach, audit or enforcement event. Since HIPAA violations under certain circumstances also can give rise to felony criminal liability, boards of directors and other leaders of Covered Entities and business associates also will want to ensure that their HIPAA compliance policies and practices also are incorporated and monitored by management as part of their organization’s overall Federal Sentencing Guideline Compliance programs and practices.

About The Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely known for work, teachings and publications on HIPAA and other privacy and data security concerns earned in connection with her more than 28 years’ of involvement advising and representing business and government clients domestically and internationally about workforce and human resources, employee benefits; health care; insurance and financial; privacy and data security and other performance management, regulatory, internal controls and other compliance, risk management, public policy and operational other key concerns.

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, past Group Chair and current Defined Contribution Plans Committee Co-Chair, Groups and Substantive Committee and Membership Committee Members, past Welfare Plans Committee Chair and Co-Chair, and former Fiduciary Responsibility Vice Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current ABA International Section Life Sciences Committee Vice Chair, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, former ABA Joint Committee on Employee Benefits Council Representative and Marketing Committee Chair and a prolific author and highly popular speaker and consultant, Ms. Stamer helps management manage.

Ms. Stamer’s legal and management consulting work throughout her nearly 30-year career has focused on helping organizations and their management use the law and process to manage people, process, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps public and private, domestic and international businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup workforce and other legal and operational crises large and small that arise in the course of operations.

Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. She supports her clients both on a real-time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or contact Ms. Stamer via email here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

NLRB Helps Union Force Another Health Care Employer To Recognize & Bargain With Union

March 13, 2014

Hospitals, skilled nursing and other health care organizations need to be concerned about union organizing of their employees in light of the growing success of unions with the aid of the pro-union support and agenda of the National Labor Relations Board (NLRB) under the Obama Administration’s leadership. The Administration’s goal of telling health care providers what to do extends well beyond Medicare and Medicaid into their workforce and terms and conditions of employment.

On February 21, 2014, for instance, the Obama Administration helped the Service Employees International Union (the Union) force Holy Cross Youth and Family Services, Inc., d/b/a Kairos Healthcare (the Employer), a provider of drug and alcohol rehabilitation services, to recognize and bargain with the over terms and conditions of employees with the Union by securing a court order forcing the employer to recognize and bargain with the Union.

Ruling in a lawsuit filed by the NLRB against the Employer on February 21, a federal court judge for the Eastern District of Michigan ordered upheld the allegations made in August 23, 2013 by the National Labor Relations Board (NLRB) Detroit, Michigan Regional Office that the Employer violated the National Labor Relations Act when it withdrew recognition from Local 517M, made unilateral changes to employees’ terms and conditions of employment without affording the Union an opportunity to bargain over those changes, and failed to provide relevant information to the Union to help in its bargaining with the Employer on behalf of the employees.

The Regional Office sought, and the Board authorized, seeking interim injunctive relief to return the parties to the bargaining table pending final resolution of the matter, to require the Employer to provide the Union with the information it requested and, upon request, to rescind the unilateral changes made to employees’ terms and conditions of employment.

On February 21, 2014, the District upheld the Regional Office’s action. It ruled that an interim injunction was appropriate to prevent loss of Union support, to keep the employees’ right to bargain with their Employer through their chosen bargaining representative, and to provide the Union with the information it needs to evaluate and make bargaining proposals while the administrative case is pending before the Board.

The case is one of a growing number of actions where the NLRB has used is powers to help Unions force health care and other employers to yield to union demands. See e.g., Specialty Healthcare and Rehabilitation of Mobile, Board Case No. 15-CA-68248 (reported at 357 NLRB No. 174) (6^th Cir. decided August 15, 2013 under the name Kindred Nursing Centers East, LLC f/k/a Specialty Healthcare and Rehabilitation of Mobile v. NLRB).

These decisions should remind health care and other employers of the highly union-friendly bent of the NLRB under the current administration, as well as the hazards of mishandling efforts to defend against union organizing and other protected activities under the NLRA. Beyond the obligation to recognize and bargain with properly certified collective bargaining unions, the NLRB and other federal labor laws also grant employees a host of other protections. Among these are recently affirmed rights-even for a worker not represented by a union – to insist another employee be present when participating in disciplinary and certain other meetings with management, rules limit the ability of employers to prohibit or restrict employees requiring employees to keep confidential and not discuss among each other salary, wages or other terms of compensation or employment terms and conditions, and others. The Obama Administration has made known its desire to expand these rights further and has carried out an aggressive legislative, regulatory and enforcement campaign in pursuit of this goal since taking office. For this reason, health care or other organizations should seek the advice and assistance of qualified legal counsel experienced with labor management relations matters to review policies for compliance, to prepare and administer anti-organizing activities, and to evaluate and respond to union organizing or bargaining activities.

For More Information Or Assistance

If you need assistance responding to health industry staffing and workforce, regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD, and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Board Certified in Labor and Employment Law, Ms. Stamer’s experience includes continuous involvement in advising and representing health care organizations about employment, labor-management, peer review and staffing and other workforce management and compensation concerns. Ms. Stamer also continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

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Posted by Cynthia Marcotte Stamer

CMS Releases New Eligible Professionals Guide On Stage 2 EHR Incentive Program

September 18, 2013

CMS just released An Eligible Professional’s Guide to Stage 2 of the EHR Incentive Programs, which provides a comprehensive overview of Stage 2 of the EHR Incentive Programs for eligible professionals. The guide outlines criteria for Stage 2 meaningful use, 2014 clinical quality measure reporting, and 2014 EHR certification including Chapters on;

What is Stage 2 of the EHR Incentive Programs?
What are the requirements under Stage 2 of Meaningful Use?
How will clinical quality measures (CQMs) change?
Resources

The guide can be found on the Educational Resources page of the EHR website.

Health care providers and their vendors and advisors using these resources also are reminded to ensure that their business associate agreements, privacy practices notices and other privacy and data security processes, policies, and procedures are updated to comply with changes to the Privacy, Security, Breach Notification and other requirements he for the protection and handling of personal health information including electronic personal health information of the Health Insurance Portability & Accountability Act (HIPAA) as amended by the HITECH Act. The Final Omnibus Regulations published by the Office of Civil Rights (OCR) generally took effect earlier this year except that the regulations set next Monday, September 23, 2013 as the deadline for updating business associate agreements and the effective date for the extension of most HIPAA requirements to business associates. As demonstrated by recent enforcement actions by OCR, Health care providers and other covered entities, their business associates and advisors continuously reconfirm that their systems and arrangements continue to comply with these requirements as they make updates.

For More Information Or Assistance

If you need assistance responding to EHR, HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information on this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

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Posted by Cynthia Marcotte Stamer

OCR Shares Model Privacy Notices 1 Week Before Deadline For Updated Business Associate Agreements

September 16, 2013

A week before the September 23, 2013 deadline for all health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates to have updated their business associate agreements to comply with the Final Omnibus HIPAA Rule, the Department of Health & Human Services Office of the National Coordinator for Health Information Technology (ONC) and the Office for Civil Rights (OCR) today (September 16, 2013) released Model Notices of Privacy Practices (Notices) for health care providers and health plans to use to communicate with their patients and plan members. With penalties and enforcement continuing to rise, Covered Entities and their business associates should take appropriate steps to review and update their privacy and breach notification policies and procedures, privacy officer appointments, notices of privacy practices, business associate agreements and other HIPAA compliance and risk management documentation, practices, procedures and coverage, breach notification and other HIPAA compliance and risk management practice.

Model HIPAA Notices

Developed collaboratively by ONC and OCR the Notices available here designed in the following three different styles are designed for users to customize to fit their specific needs and practices:

A notice in the form of a booklet;
A layered notice with a summary of the information on the first page and full content on the following pages; and
A notice with the design elements of the booklet, but that is formatted for full-page presentation.

Use of these model Notices is optional. While the agencies designed the Notices to let Covered Entities to use these models by entering some of their own information into the model, such as contact information, and then printing for distribution and posting on their websites, Covered Entities should consult with legal counsel to determine the suitability of the Notices generally for their entity’s use and any customization, if any, that may be recommended or required to a Notice if the Covered Entity decides rely upon a model Notice to prepare its Notice of Privacy Practices. To facilitate any tailoring, the agencies provided a text-only version for Covered Entities wishing only wish to use the content with or without tailoring.

September 23 Business Associate Agreement Update Deadline

September 23, 2013 also is the final deadline established in the Final Omnibus HIPAA Rule for Covered Entities and their business associations to update the business associate agreements required by HIPAA to reflect application of the breach notification, business associate, and many of HIPAA’s requirements to directly cover business associates and other aspects of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009. While HHS published a Sample Business Associate Agreement last June to aid Covered Entities and their business associates with understanding the business associate agreement requirements as impacted by the Omnibus Final HIPAA Rule, it also made clear that Covered Entities and their business associates should tailor their business associate agreements to fit their specific circumstances and relationships. OCR National Office and regional officials speaking about their findings about past business associate agreement compliance have indicated that their audit and enforcement activities show widespread compliance issues among Covered Entities and business associates with the original business associate agreements. OCR clearly expects Covered Entities and their business associates to address and resolve these compliance issues going forward.

Covered Entities and their business associates are increasingly at peril if caught violating HIPAA’s Privacy, Security or Breach Notification rules. With the HITECH Act Breach Notification rules now requiring Covered Entities to self-disclose breaches, OCR becomes aware of breaches much more easily. Coupled with the HITECH Act’s increase in sanctions for HIPAA violations, Covered Entities and, beginning September 23, 2013, their business associates face rising risks for violating HIPAA. See, e.g. HHS Settles with Health Plan in Photocopier Breach Case; WellPoint Settles HIPAA Security Case for $1,700,000; Shasta Regional Medical Center Settles HIPAA Security Case for $275,000; Idaho State University Settles HIPAA Security Case for $400,000; and HHS announces first HIPAA breach settlement involving less than 500 patients.

In response to the updated Final Regulations and these expanding HIPAA enforcement and exposures, all Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable. In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if tightening their policies, practices, documentation or training is necessary or advisable.

For More Information Or Assistance

If you need assistance responding to HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information on this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

CMS To Host Provider Webinar To Celebrate National Health IT Week

September 13, 2013

In celebration of the third annual National Health IT Week is September 16-20, the Centers for Medicare & Medicaid Services (CMS) will host several webinars and launching new eHealth tools and resources that it intends to help providers participate in eHealth programs. These programs may be of interest to providers as well as payers who are interested in what providers are doing to use eHealth tools.

Details of Webinar

The eHealth Provider Webinar will be held on Thursday, September 19^th from 12:00 p.m. to 1:30 p.m. ET. CMS plans to present an overview of the eHealth programs and its eHealth initiative—an initiative that aligns health IT and electronic standards programs on:

Administrative Simplification
eRx Incentive Program
ICD-10
Quality Measurement

A portion of the webinar will also be dedicated to Q&A.

Registration Information

Space is limited. Register now to secure your spot for the eHealth Provider Webinar. Once registration is complete, you will receive a follow-up email with step-by-step instructions on how to log-in to the webinar. Listserv messages are sent prior to each webinar session with registration information.

If you’d like to view past webinars, the PowerPoint presentations and recordings can now be accessed on the Resources page of the eHealth website. For more information about CMS’ eHealth Initiatives, visit the CMS eHealth website for the latest news and updates on CMS’ eHealth initiatives.

For More Information Or Assistance

If you need assistance responding to this invitation or with other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, CMS, eHealth, Health IT, HHS, HIPAA Privacy, Hospital, Physicians, Providers, Security | Permalink
Posted by Cynthia Marcotte Stamer

Tell HHS What You Think-Comment On HHS Strategic Plan Now!

September 9, 2013

Health care providers, health plans, employers and others concerned about the regulatory and enforcement activities of the Department of Health & Human Services (HHS) can make their concerns known by speaking up now. Share your input on the draft HHS strategic plan that will guide HHS’ regulatory and enforcement agenda for the next 4 years.

Every 4 years, HHS updates its strategic plan, which describes its work to address complex, multifaceted, and ever-evolving health and human service issues, including:

Health Care
Research and Innovation
Prevention and Wellness

HHS is inviting public input on the draft HHS Strategic Plan for FY 2014-2018. The comment period is open until October 15, 2013. Individuals or organizations wishing to respond to this invitation can read the HHS Strategic Plan FY 2014-2018 (Draft) and submit your comments several ways including:

Submit your comments online here
Via Email to: strategicplanning@hhs.gov
Via Fax: (202) 690-8252
U.S. Mail (not recommended as security screening results in significant delay.

For More Information Or Assistance

If you need assistance responding to this invitation for comment or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

Court Upholds NLRB Certification of CNAs As Bargaining Union Based On NLRB Modified Community Of Interest Test

August 21, 2013

Hospitals, skilled nursing and other health care organizations facing or concerned about union organizing or their nursing or other staffs employees should consider an apparent change in National Labor Relations Board (NLRB) certification policy upheld when the Sixth Circuit ruling upheld the NLRB’s certification of a bargaining unit consisting exclusively of certified nursing assistants (CNAs) at Specialty Healthcare and Rehabilitation of Mobile (Specialty) nursing home and enforced the Board’s order finding that Specialty’s refusal to bargain with the certified unit violated Section 8(a)(5) and (1) of the National Labor Relations Act (NLRA).

Specialty Healthcare and Rehabilitation of Mobile, Board Case No. 15-CA-68248 (reported at 357 NLRB No. 174) (6^th Cir. decided August 15, 2013 under the name Kindred Nursing Centers East, LLC f/k/a Specialty Healthcare and Rehabilitation of Mobile v. NLRB), arose after the union had petitioned to represent a unit of 53 full-time and part-time CNAs, Specialty claimed that the smallest appropriate unit must include 86 other service and maintenance employees.　 The NLRB Regional Director found the unit appropriate and conducted the election, which the union won.　 The NLRB granted review, asked the parties and public for their views on eight questions on community of interest unit determinations in the non-acute care healthcare industry, and ultimately issued a decision upholding the unit determination and the union’s election victory.

In its decision, the Board overruled Park Manor Care Center, 305 NLRB 872 (1991), which applied a “pragmatic or empirical community of interests approach” to determining unit appropriateness in nursing homes.　 Instead, the Board ruled that it would apply the traditional test to evaluate appropriateness, which examines whether a proposed unit is readily identifiable and shares a community of interest distinct from other employees.　 Then, the Board explained, if “a party contends that a petitioned-for unit containing employees readily identifiable as a group who share a community of interest is nevertheless inappropriate because it does not contain additional employees, the burden is on the party so contending to show that the excluded employees share an overwhelming community of interest with the included employees.”　 Because the CNA-only unit was readily identifiable and shared a distinct community of interest, and because Specialty failed to show that the excluded service and maintenance employees shared an overwhelming community of interest with the CNAs, the Board certified the unit and the union’s victory.　 Specialty refused to bargain, and this technical NLRA Section 8(a)(5) proceeding followed.

The Sixth Circuit affirmed the Board’s order and its clarification of the community-of-interest test.　 First, rejecting Specialty’s argument that the Board did not merely embrace the traditional community-of-interest test but instead improperly created an entirely new framework, the court held that the Board permissibly “adopted a community-of-interest test based on some of the Board’s prior precedents, and . . . did explain its reasons for doing so.”　 In so holding, the court explicitly recognized the ambiguity in the Act’s command that bargaining units must be “appropriate,” and observed that the Board merely granted Judge Posner’s “wish that the Board would give [the traditional community-of-interest test] ‘a precise meaning.’” Slip op. at 13 (quoting Cont’l Web Press v. NLRB, 742 F.2d 1087, 1090 (7th Cir. 1984)).

Next, the court concluded that the Board acted within its discretion in requiring a party claiming that the smallest appropriate unit must include additional employees to show that the excluded employees share an “overwhelming community of interest” with the proposed unit.　 Indeed, the court explained that “[t]he Board has used the overwhelming-community-of-interest standard before, so its adoption [here] is not new.”　 After citing numerous cases, including the D.C. Circuit’s Blue Man Vegas LLC v. NLRB, 529 F.3d 417 (D.C. Cir. 2008), the court agreed that the Board merely clarified existing law, overruled any inconsistent precedent, appropriately placed the burden of proving overwhelming community of interest on the employer (who typically possesses the information to make that case), and explained its reasons for doing all of the above.

Turning to Specialty’s third defense, the court concluded that the Board’s test did not run afoul of Section 9(c)(5), which prohibits the Board from finding “the extent to which the employees have organized . . . controlling” in making unit determinations.　 To the contrary, the court noted that the Board first engaged in an independent community of interest determination to find out whether the proposed CNA-only unit was appropriate “aside from the fact that the union had organized it.”　 Further, “[a]s long as the Board applies the overwhelming community of interest standard only after the proposed unit has been shown to be prima facie appropriate, the Board does not run afoul of the statutory injunction that the extent of the union’s organization not be given controlling weight.”　 Slip op. at 19 (internal quotations omitted and emphasis in original).

Finally, the court held that “the Board did not abuse its discretion in adopting a generally applicable rule through adjudication instead of rule making because NLRB v. Bell Aerospace Co. Div. of Textron, Inc., 416 U.S. 267, 294 (1974), holds both that ‘the Board is not precluded from announcing new principles in an adjudicative proceeding and that the choice between rule making and adjudication lies in the first instance within the Board’s discretion.’”

The Court’s opinion is available here.

The Speciality ruling reminds health care and other employers of the highly union-friendly bent of the NLRB under the current administration, as well as the hazards of mishandling efforts to defend against union organizing and other protected activities under the NLRA. Beyond the obligation to recognize and bargain with properly certified collective bargaining unions, the NLRB and other federal labor laws also grant employees a host of other protections. Among these are recently affirmed rights-even for a worker not represented by a union – to insist another employee be present when participating in disciplinary and certain other meetings with management, rules limit the ability of employers to prohibit or restrict employees requiring employees to keep confidential and not discuss among each other salary, wages or other terms of compensation or employment terms and conditions, and others. For this reason, health care or other organizations should seek the advice and assistance of qualified legal counsel experienced with labor management relations matters to review policies for compliance, to prepare and administer anti-organizing activities, and to evaluate and respond to union organizing or bargaining activities.

For More Information Or Assistance

If you need assistance responding to HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD, and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Board Certified in Labor and Employment Law, Ms. Stamer’s experience includes continuous involvement in advising and representing health care organizations about employment, labor-management, peer review and staffing and other workforce management and compensation concerns. Ms. Stamer also continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, collective bargaining, Employment, Health Care, HHS, HIPAA Privacy, Hospital, labor-management, NLRB, nursing home, Security, Union Organizing | Permalink
Posted by Cynthia Marcotte Stamer

$1.2M HIPAA Settlement Results From Improper Copier Disposal

August 15, 2013

Be careful when repurposing or disposing of copiers and other equipment and media that may contain protected health information. That’s the message the Office of Civil Rights is sending health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates in its August 14, 2013 announcement of a $1.2 million plus settlement agreement with Affinity Health Plan, Inc. (Affinity) under the Health Insurance Portability & Accountability Act Privacy and Security Rules.

According to OCR, the non-profit New York area managed care plan Affinity will pay $1,215,780 and take other corrective actions to settle alleged HIPAA violations under the Affinity Resolution Agreement and CAP (Affinity Settlement). The settlement comes as the September 24, 2013 deadline for health plans, health care providers, health care clearinghouses (Covered Entities) and their business associates to update the written business associate agreements that HIPAA requires exist before business associates can be allowed to create, use, access or disclose personally identifiable health care information protected by HIPAA (PHI) to carry out HIPAA-covered functions on behalf of a Covered Entity to comply with changes to HIPAA’s implementing regulations adopted by OCR earlier this year. Health plans and other Covered Entities should take timely action to confirm that their existing procedures appropriate safeguards to protect PHI when using or disposing of copiers or other equipment or media as well as to implement business associate or other policy, procedures or training updates required to comply with the updated HIPAA rules.

HIPAA Updates Require Breach Notification, Tightened Other HIPAA Requirements

HIPAA generally requires that Covered Entities (and after September 24, 2013, their business associates) safeguard and restrict the use, access or disclosure of PHI as required by HIPAA. The HITECH Act amended these requirements to tighten certain of these requirements and restrictions, to expand the sanctions for violation of these requirements, to require Covered Entities and their business associates to provide notification of breaches of unsecured PHI to individuals whose information was breached, OCR and in some cases, the media, and made certain other changes to the original requirements of HIPAA. Earlier this year, OCR amended and restated its original Privacy and Security Rules here (2013 Final Rule) to comply with changes in the regulations resulting from these HITECH Act amendments beginning last March, but set the deadline for updating business associate agreements to meet these updated requirements at September 23, 2013.

The 2013 Final Rule and other OCR guidance makes clear that OCR expects Covered Entities and their business associates appropriately to safeguard PHI stored in computers, hard drives, and other digital media until it is properly disposed in accordance with the updated standards required by HIPAA as implemented under the 2013 Final Rule. HITECH Breach Notification Rule requires HIPAA-covered entities to notify HHS of a breach of unsecured protected health information, including breaches resulting from failure to properly secure PHI stored in digital format until it has been destroyed in accordance with the standards established by the 2013 Final Rule. OCR previously has sanctioned other Covered Entities for failed to properly destroy or safeguard PHI stored in digital format on computer or other equipment before abandoning or disposing of that equipment. The Affinity Settlement reaffirms OCR’s concern that Covered Entities meet these disposal requirements when replacing or abandoning equipment containing electronic PHI.

Affinity Settlement Highlights

According to the August 14, 2013 OCR announcement of the settlement, the settlement resulted from an investigation initiated after Affinity filed a breach report with OCR on April 15, 2010, as required by the Health Information Technology for Economic and Clinical Health Act (HITECH Act.)

In its breach report, Affinity indicated that it was informed by a representative of CBS Evening News that, as part of an investigatory report, CBS had purchased a photocopier previously leased by Affinity. CBS informed Affinity that the copier that Affinity had used contained confidential medical information on the hard drive.

Affinity estimated in its breach report that up to 344,579 individuals may have been affected by this breach. OCR’s investigation indicated that Affinity impermissibly disclosed the protected health information of these affected individuals when it returned multiple photocopiers to leasing agents without erasing the data contained on the copier hard drives. In addition, OCR reports its investigation revealed that Affinity failed to incorporate the electronic protected health information (ePHI) stored on photocopier hard drives in its analysis of risks and vulnerabilities as required by the Security Rule, and failed to implement policies and procedures when returning the photocopiers to its leasing agents.

In addition to the $1,215,780 payment, the Affinity Settlement includes a corrective action plan requiring Affinity to use its best efforts to retrieve all hard drives that were contained on photocopiers previously leased by the plan that remain in the possession of the leasing agent, and to take certain measures to safeguard all ePHI.

Learn From Affinity Lesson On Proper Disposal Procedures

Like prior OCR settlements stemming from inadequate security for PHI when transitioning equipment, media or facilities, the Affinity Settlement sends another reminder to Covered Entities and their business associates again of the importance of using appropriate procedures to protect or dispose of PHI when replacing or redeploying equipment or media that may contain PHI.

“This settlement illustrates an important reminder about equipment designed to retain electronic information: Make sure that all personal information is wiped from hardware before it’s recycled, thrown away or sent back to a leasing agent,” said OCR Director Leon Rodriguez. “HIPAA covered entities are required to undertake a careful risk analysis to understand the threats and vulnerabilities to individuals’ data, and have appropriate safeguards in place to protect this information.”

OCR has published guidance concerning HIPAA’s requirements for the proper safeguarding and disposal of media and equipment in the 2013 Final Rule and other guidance. Concerning the proper disposition of copiers that may have PHI stored on their hard drives or in other digital formal, OCR in the Affinity Settlement recommended that Covered Entities and their associates also review the Federal Trade Commission’s Guidance On Safeguarding Sensitive Data Stored In The Hard Drives Of Digital Copiers and the National Institute of Standards and Technology has issued Guidance On Assessing The Security Of Multipurpose Office Machines. Covered Entities and their business associates should use this and other guidance to ensure that they can demonstrate that appropriate practices and procedures have been used to when disposing of or repurposing copies or other equipment that may contain electronic PHI.

HIPAA Regulation Updates Require Other Updates Beyond Disposal Procedures

In addition to addressing the concerns that lead to the Affinity Settlement, Covered Entities and their business associates also should verify that their practices, policies, privacy notices, business associate agreements, and training also are updated to comply with updates to the updated 2013 Final Rule adopted by OCR earlier this year here.

Since passage of the HITECH Act, OCR officials have warned Covered Entities to expect an omnibus restatement of its original regulations. While OCR had issued certain regulations implementing some of the HITECH Act changes, it waited to publish certain regulations necessary to implement other HITECH Act changes until it could complete a more comprehensive restatement of its previously published HIPAA regulations to reflect both the HITECH Act amendments and other refinements to its HIPAA Rules. The 2013 Regulations published today fulfill that promise by restating OCR’s HIPAA Regulations to reflect the HITECH Act Amendments and other changes and clarifications to OCR’s interpretation and enforcement of HIPAA.

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If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

OCR Shares New Tools to Educate Consumers and Providers about HIPAA Privacy and Security

April 30, 2013

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has developed an array of new tools to educate consumers and health care providers about the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.

Many consumers are unfamiliar with their rights under the HIPAA Privacy Rule. With that in mind, OCR has posted a series of factsheets, also available in eight languages, to inform consumers about their rights under the HIPAA Privacy Rule. These materials are available on OCR’s website here.

The fact sheets compliment a set of seven consumer-facing videos released earlier this year on OCR’s YouTube channel. An additional video, The HIPAA Security Rule, has been designed for providers in small practices and offers an overview of how to establish basic safeguards to protect patient information and comply with the Security Rule’s requirements. The videos are available on the HHS OCR YouTube Channel at here.

OCR has also launched three modules for health care providers on compliance with various aspects of the HIPAA Privacy and Security Rules, available at Medscape.org:

Patient Privacy: A Guide for Providers at here;
HIPAA and You: Building a Culture of Compliance here; and
Examining Compliance with the HIPAA Privacy Rule here.

The Medscape modules offer free Continuing Medical Education (CME) credits for physicians and Continuing Education (CE) credits for health care professionals.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters.

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experience with health plan privacy and data security matters, Ms. Stamer serves as the scribe for the ABA JCEB Annual Technical Session meeting with OCR each May and has worked, spoken and published extensively on these and other privacy and data security concerns and controls. Extensively published and a popular speaker on HIPAA and other data security matters, Ms. Stamer works extensively with health care providers, health plans, employers, insurance and financial services, technology and other clients on privacy, data seurity and other privacy and cybercrime concerns. She also serves as the Scribe for the ABA JCEB Agency Techical Sessions Meetings with the Office of Civil Rights which occur each May in Washington, D.C.

Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. ©2013 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Covered Entities, Data, Health Care, Health Plans, HIPAA, HIPAA Audits, OCR, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

HHS Publishes Medicaid Expansion Final Regs, Invites Public Comment

April 1, 2013

The Department of Health & Human Services (HHS) has published its final rule with a request for comments that provides, effective January 1, 2014, the federal government will pay 100 percent of the cost of certain newly eligible adult Medicaid beneficiaries. These payments will be in effect through 2016, phasing down to a permanent 90 percent matching rate by 2020. The Affordable Care Act authorizes states to expand Medicaid to adult Americans under age 65 with income of up to 133 percent of the federal poverty level (approximately $15,000 for a single adult in 2012) and provides unprecedented federal funding for these states.

Under the Affordable Care Act, states that cover the new adult group in Medicaid will have 100 percent of the costs of newly eligible Americans paid for by the federal government in 2014, 2015, and 2016. The federal government’s contribution is then phased-down gradually to 90 percent by 2020, and remains there permanently. For states that had coverage expansions in effect prior to enactment of the Affordable Care Act, the rule also provides information about the availability of an increased FMAP for certain adults who are not newly eligible.

For the full text of the final rule, see http://www.ofr.gov/inspection.aspx.

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OCR Invites Comments On Plans to Survey HIPAA Covered Entities Audited Under 2012 HIPAA Audit Program

March 25, 2013

The Department of Health & Human Services (HHS) Office of Civil Rights (OCR) wants to ask the 115 health plans, health care clearinghouses, and health care providers (covered entities) that OCR audited in 2012 for compliance with Privacy and Security Rules of the Health Insurance Portability & Accountability Act (HIPAA) under its HIPAA Audit Program to share feedback about their experience. The planned survey announcement follows OCR’s recent released of restated HIPAA Privacy & Security Rules scheduled to take effect in September, 2013 and as OCR continues and expanding its HIPAA Audit Program in 2013. All together, the signs are clear that covered entities should update and strengthen their HIPAA compliance and risk management practices to withstand the tightened rules and enforcement.

OCR initiated the HIPAA Audit Program in 2012 to comply with Section 13411 of the Health Information Technology for Economic and Clinical Health Act’s requirement that it audit covered entity and business associate compliance with the HIPAA privacy, security, and breach notification rules. While it continues its HIPAA Audit Program in 2013, OCR also is evaluating the effectiveness of the HIPAA Audit Program audits in 2012.

To this end, OCR currently is conducting a review of the HIPAA Audit program to determine its efficacy in assessing the HIPAA compliance efforts of covered entities. As part of that review, OCR plans to ask covered entities audited under the HIPAA Audit Program in 2012 to complete an online survey about their experience. In anticipation of its conduct of the proposed surveys, OCR is inviting public comment on the burden to Covered Entities to complete the planned online survey, which OCR estimates will take two hours to complete through May 20, 2013. According to OCR, the survey will gather information on the effect of the audits on the audited entities and the entities’ opinions about the audit process. The online survey will be used to:

Measure the effect of the HIPAA Audit program on covered entities;
Gauge their attitudes towards the audit overall and in regards to major audit program features, such as the document request, communications received, the on-site visit, the audit report findings and recommendations;
Obtain estimates of costs incurred by covered entities, in time and money, spent responding to audit-related requests;
Seek feedback on the effect of the HIPAA Audit program on the day-to-day business operations; and
Assess whether improvements in HIPAA compliance were achieved as a result of the Audit program.

OCR says it will use the information, opinions, and comments collected using the online survey to produce recommendations for improving the HIPAA Audit program.

For instructions to comment or more details, see here.

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5/18 Deadline to Register For 5/19 CMS Provider Call on Medicare and Medicaid EHR Meaningful Use Incentive Programs

May 17, 2011

Wish you knew more about how to use electronic health records (EHRs) to earn incentive payments from the Centers for Medicare & Medicaid Services (CMS)? CMS plans to host a national provider education call to help you learn more about meaningful use on Thursday, May 19 at 2:30 p.m. EDT. During the call, CMS plans to discuss:

The definition of meaningful use
The requirements for Stage 1 of meaningful use (2011 and 2012)
How to attest to having met meaningful use
Overview of the meaningful use objectives specification sheets
- Stage 1 EHR Meaningful Use Specification Sheets for Eligible Professionals
- Stage 1 EHR Meaningful Use Specification Sheets for Eligible Hospitals
Q&A about meaningful use

In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation. Registration will close at 2:30 p.m. EDT on May 18, 2011, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time. In order to register, you should:

Visit the registration page.
Fill in all required information and click “Register.”
You will be taken to the “Thank you for registering” page and will receive a confirmation email shortly thereafter. Please save this page in case your server blocks the confirmation emails. (If you do not receive the confirmation email, check your spam/junk mail filter as it may have been directed there.)
If assistance for hearing impaired services is needed, please email medicare.ttt@palmettogba.com no later than three business days before the call.

Prior to the call, presentation materials will be made available in the “Upcoming Events” section of the Spotlight page on the CMS EHR website.

Want more information about the EHR Incentive Programs?
Make sure to visit the EHR Incentive Programs website for the latest news and updates on the EHR Incentive Programs.

Sixty-two Regional Extension Centers (RECs) across the nation are prepared to offer customized, on-the-ground assistance for eligible professionals and hospitals registering for the CMS EHR Incentive Programs. To locate an REC near you, visit http://www.healthit.

In addition to the May 10 call, recordings of various other recent health information privacy and data security training offered by agencies within the Department of Health and Human Services also now is avaialble on the web. For instance, the National Institute of Standards and Technology (NIST) and the Office for Civil Rights (OCR) are making presentations from the 4th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” co-hosted in Washington, D.C. on May 10 & 11, 2011 available on line for review. The training is part of a series of continuing efforts by the agencies to outreach to various parties on the Privacy and Security Rules of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA). Meanwhile, OCR’s Susan McAndrew on Monday shared insights on OCR’s HIPAA regulatory and enforcement agenda at a teleconference to be hosted by the American Bar Association Joint Committee on Employee Benefits at Noon Central on May 16, 2011. Recordings of these presentations are or will be accessible on the sponsoring organizations from their websites. For details about reviewing the May 10-11 presentations, see the 2011 HIPAA Conference website here. For details about the May 16 teleconference, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. On May 3, 2011, Ms. Stamer served as the appointed scribe for the ABA Joint Commitee on Employee Benefits Agency meeting with OCR and will moderate a teleconference featuring comments by OCR’s Susan McAndrew for the Joint Committee on Employee Benefits scheduled for May 16. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others.. Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Leave a Comment » | Academic medicine, ASC, DEA, Disease Management, DME, Doctor, Electronic Health Records, Electronic Medical Records, Employer, Genetic Information, GINA, Health Care Provider, Health IT, Health Plan, HIPAA, HITECH Act, Hospital, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Mental Heatlh, OCR, Physician | Tagged: Health Care, HIPAA, Medical Confidentiality, OCR< Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

OCR/NIST Share Training Online, OCR’s McAndrew To Speak On May 16 Teleconference

May 10, 2011

The National Institute of Standards and Technology (NIST) and the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) are making presentations from the 4th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” co-hosted in Washington, D.C. on May 10 & 11, 2011 available on line for review. The training is part of a series of continuing efforts by the agencies to outreach to various parties on the Privacy and Security Rules of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA). Meanwhile, OCR’s Susan McAndrew is scheduled to share insights on OCR’s HIPAA regulatory and enforcement agenda at a teleconference to be hosted by the American Bar Association Joint Committee on Employee Benefits at Noon Central on May 16, 2011.

The Security Rule sets federal standards to protect the confidentiality, integrity and availability of electronic protected health information by requiring HIPAA covered entities and their business associates to implement and maintain administrative, physical and technical safeguards. Presentations cover a variety of current topics including updates on HHS health information privacy and security initiatives, OCR’s enforcement of health information privacy and security activities, integrating security safeguards into health IT and security automation, insider threat trends and safeguards, and more.

The conference is designed to explore the current health information technology security landscape and the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, the agencies share their practical strategies, tips and techniques for implementing the HIPAA Security Rule.

For details about reviewing the May 10-11 presentations, see the 2011 HIPAA Conference website here. For details about the May 16 teleconference, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

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Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules

August 3, 2010

One of the nation’s largest drug store chains, Rite Aid Corporation and its 40 affiliated entities (Rite Aid) will pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The U.S. Department of Health and Human Services (HHS) Office of Civil Rights announcement of the HIPAA resolution agreement with Rite Aid and the concurrent negotiation of a separate consent order of potential FTC Act violations between Rite Aid and the Federal Trade Commission (FTC) follows HHS’ announcement of proposed changes to its HIPAA Privacy Rules and associated penalties in response to changes enacted under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The Rite Aid settlement and the proposed Privacy Rule changes illustrate the growing penalty risks that health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) face for violating the Privacy Rules.

Rite Aid Resolution Agreement

The Rite Aid resolution agreements settle charges that Rite Aid failed to appropriately safeguard the privacy of its customers when disposing of identifying information on pill bottle labels and other health information. The settlements apply to all of Rite Aid’s nearly 4,800 retail pharmacies and follow an extensive joint investigation by the HHS Office for Civil Rights (OCR) and the FTC.

OCR opened its investigation of Rite Aid after television media videotaped incidents in which pharmacies were shown to have disposed of prescriptions and labeled pill bottles containing individuals’ identifiable information in industrial trash containers that were accessible to the public in a variety of Rite Aid locations in cities across the United States. OCR and FTC previously settled a similar case involving the national drug store chain CVS in February 2009.

The HIPAA Privacy Rule requires covered entities to safeguard the privacy of patient information and other “protected health information” including during its disposal. In addition to the detailed requirements for protection and safeguarding of protected health information and electronic protected health information under the Privacy Rules, breach notification rules added to HIPAA under the HITECH Act also generally require that Covered Entities investigate and provide timely notification of breach to patients, OCR and in some cases the media when “unsecured protected heath information” is breached. Meanwhile, the FTC Act and associated regulations require those retailers and certain other parties receiving personal financial information to comply with certain requirements for the protection and use of that information and to provide certain notifications of their privacy polices for protecting personal financial information.

The joint OCR and the FTC investigations raised concerns that:

Rite Aid failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
Rite Aid failed to adequately train employees on how to dispose of such information properly; and
Rite Aid did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Under the HHS resolution agreement, Rite Aid agreed to pay a $1 million resolution amount to HHS and must implement a strong corrective action program under which Rite Aid agreed to:

Revise and distribute its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
Train workforce members on these new requirements;
Conduct internal monitoring; and
Engage a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

In addition, under its FTC consent order, Rite Aid separately agreed to external, independent assessments of its pharmacy stores’ compliance with the FTC consent order.

The HHS corrective action plan will be in place for three years; the FTC order will be in place for 20 years.

Proposed Privacy Rule Changes

The Rite Aid resolution agreement and consent order follows the July 8, 2010 publication by OCR of proposed changes to its existing HIPAA Privacy, Security, and Enforcement Rules in response to amendments enacted under the HITECH Act. Because of the lead time required to implement needed changes in policies, technology and training, Covered Entities need to begin preparations to adjust their health information privacy and data security policies and practices in anticipation of the finalization and implementation of these rules as well as to act quickly to submit their comments about the proposed changes. .

The more than 220 page Notice of Proposed Rulemaking (NPRM) proposes to revise the existing Standards for Privacy of Individually Identifiable Health Information (Privacy Rule); the Security Standards for the Protection of Electronic Protected Health Information (Security Rule); and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with HIPAA and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also is regularly conducts training on HIPAA and other health industry compliance, management and operations matters. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here.

Leave a Comment » | Affordable Care Act, American's Affordable Health Choices Act, Doctor, E-Prescribing, Electronic Medical Records, Employer, FACTA, Health Care, Health Care Reform, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Indian Health, Inpatient Rehabilitation Facility, Laws, Meaningful Use, Medicare, Medicare Advantage, Medicare Prescription Drug Program, OCR, Pharmacy, Prescription Drugs, Technology, Telemedicine | Tagged: Breach Notification, Data Security, FACTA, FTC, HIPAA, HITECH, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

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