Health care providers, health insurers, group health plans and health care clearinghouses (Covered Entities), their business associates and their leaders need to ensure the adequacy of the security of internet portals and applications used to create, use, access or disclose protected health information (PHI) and should establish and administer ongoing procedures to monitor and maintain adequate PHI security on an ongoing basis in light of a new Health Insurance Portability & Accountability Act (HIPAA) Privacy, Security and Breach Notification Rule (“HIPAA Rules”) Resolution Agreement with St. Elizabeth’s Medical Center (SEMC) announced today (July 10, 2015) by the Department of Health & Human Services Office of Civil Rights (OCR). Concurrently, the Resolution Agreement also reaffirms the growing involvement of employees and other workforce members as HIPAA “whistleblowers” as well as the need for Covered Entities, business associates and their leaders to ensure that they include and administer documented requirements for board reporting and oversight in their HIPAA compliance and risk management activities.
To settle OCR charges that the Brighton, Massachusetts’s based hospital system violated the HIPAA Rules resulting from OCR’s investigation of a November 16, 2012 complaint made to OCR by SEMC workforce members, SEMC has agreed to pay $218,400 and to implement a “robust corrective action plan” to correct deficiencies in its HIPAA security and other compliance revealed in the investigation.
According to OCR, OCR opened the investigation after employees complained to OCR that SEMC violated HIPAA by allowing workforce members to use an internet-based document sharing application to share and store documents containing electronic protected health information (ePHI) of at least 498 individuals without having analyzed the risks associated with such a practice. According to OCR, its investigation of the complaint revealed among other things that:
- SEMC improperly disclosed the PHI of at least 1,093 individuals;
- SEMC failed to implement sufficient security measures regarding the transmission of and storage of ePHI to reduce risks and vulnerabilities to a reasonable and appropriate level; and
- SEMC failed to timely identify and respond to a known security incident, mitigate the harmful effects of the security incident, and document the security incident and its outcome. Separately, on August 25, 2014, SEMC submitted notification to HHS OCR regarding a breach of unsecured ePHI stored on a former SEMC workforce member’s personal laptop and USB flash drive, affecting 595 individuals. A review of detailed corrective action plan imposed under the Resolution Agreement provides helpful insights about some of the steps that OCR is likely to expect Covered Entities and business associates to take to meet its security expectations for internet applications and portals. Beyond imposing a $218,400 penalty (“Resolution Amount”) against SEMC, the Resolution Agreement requires among other things that SEMC in accordance with the Resolution Agreement and to OCR satisfaction.
In announcing the Resolution Agreement, OCR Director Jocelyn Samuels sent a clear message to Covered Entities and their business associates to confirm and maintain the adequacy of security of internet portals and applications used in connection with PHI. “Organizations must pay particular attention to HIPAA’s requirements when using internet-based document sharing applications,” said OCR Director Jocelyn Samuels. “In order to reduce potential risks and vulnerabilities, all workforce members must follow all policies and procedures, and entities must ensure that incidents are reported and mitigated in a timely manner.”
- To self-assess the adequacy of its policies and workforce and operations compliance with HIPAA including conducting unannounced audits of SEMC workforce members’ familiarity and compliance with SEMC policies and procedures on transmitting ePHI using unauthorized networks; storing ePHI on unauthorized information systems, including unsecured networks and devices; removal of ePHI from SEMC; prohibition on sharing accounts and passwords for ePHI access or storage; encryption of portable devices that access or store ePHI; security incident reporting related to ePHI;
- The adequacy of workforce compliance with these policies by conducting unannounced site visits to various SEMC departments, inspections of certain laptops, smartphones, storage media and other portable devices as well as on workstations and other devices containing ePHI;
- To identify and report to OCR any material compliance issues with the policies and recommendations for improving these policies and procedures, oversight and supervision, or training;
- Develop and implement to OCR satisfaction corrections to policies, practice and training along with oversight mechanisms reasonably tailored to ensure that all SEMC workforce members follow such policies and procedures, and only use and disclose ePHI appropriately;
- Collect and retain for OCR review and approval certain documentation of compliance; and
- Conduct documented investigations of potential violations, redress and report to OCR about investigations and violations.
First, management should take special note that members of the SEMC workforce made the complaint to OCR that prompted OCR’s investigation.
As in other health care compliance areas, required workforce training coupled with HIPAA’s anti-retaliation and whistleblower protections provide encouragement if not incentives for disgruntled or well-meaning employees or other workforce members and business partners of covered entities or business associates make complaints about suspected HIPAA or other compliance concerns internally or to OCR. Management needs to take appropriate steps to ensure that its policies and processes include appropriate privacy and human resources procedures to manage both its HIPAA compliance obligations and potential retaliation and other human resources exposures that can result if these concerns are mishandled. Employee & Other Whistleblower Complaints Common Source of HIPAA Privacy & Other Complaints. Effective health plan and employer HIPAA and human resources compliance, reporting internal investigation and risk management policies and practices are critical to manage both HIPAA and other compliance exposures and the retaliation and other human resources risks that inevitably arise when employees or other workforce members or business partners raise compliance concerns or participate in compliance investigations internally or externally.
Second, the Resolution Agreement also reflects the clear expectation that management of Covered Entities and business associates make compliance with HIPAA a priority. Consistent with its recent practice, the Resolution Agreement requires management oversight and accountability for ensuring compliance with the Resolution Agreement and HIPAA by requiring an officer to attest to the fulfillment of the requirements of the Resolution Agreement. This emphasis upon requiring leadership oversight and prioritization of HIPAA compliance tracks the broader general expectations regarding responsibilities for management and boards concerning compliance with HIPAA and other federal health care increasingly articulated by HHS and other federal agencies enforcing laws subject to the Federal Sentencing Guidelines like HIPAA, See e.g. Practical Guidance for Health Care Governing Boards on Compliance Oversight. While OCR officials have indicated that the need for officer attestation like that required by the Resolution Agreement may not be required in all cases, the inclusion of these requirements coupled with these other developments sends a strong message that Boards and other management should ensure that their processes include appropriate evidence and document retention of management oversight.
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, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 27 years’ experience advising health industry clients about these and other matters. Her experience includes advising 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, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, 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 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. 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. 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.
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Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others 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 here. You can reach other recent updates and other informative publications and resources. Examples of some of these recent health care related publications include:
- McGraw Appointed New OCR Deputy Director
- Tex Docs Urged To Support Medical Board Reforms
- CMS Proposes New Quality Measures, Reporting, Other Changes For FY 2016 Psych Facilities Prospective Payment System Updates
- Great Time To Remind Patients, Employees To Check Their Immunizations Are Up To Date
- CMS Issues Last Call For Comments, Questions On Proposed Medicare Home Health Billing Templates
- HHS Proposes Stage 3 Meaningful Use EHR Incentive Programs & 2015 Edition Health IT Certification Criteria Rules
- More PQRS Guidance Released
- Former National Quality Forum Committee Co-Chair Pays $1M, Excluded From Medicare In Fraud Settlement
- State Exchange Problems Added ACA Threat Regardless of SCOTUS Decision In King v. Burwell
- Health Care Employer’s Discrimination Triggers Medicare, EEOC Prosecutions
- Health Care Providers, Provide ACO, Reimbursement Reform Input To HHS
- Extension for EPs participating in PQRS via EHR and QCDR
- Former Houston Area DME Owner To Serve 7+ Years, Pay $1.6 M In Restitution For Health Care Fraud
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 see 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.
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.
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