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.

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.

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