Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private participants–released a report last week describing U.S. healthcare cybersecurity as being in “critical condition.” This conclusion, while disheartening, shouldn’t be surprising to readers of this blog. We’ve blogged about a range of cybersecurity issues affecting health care, from the potential hacking of medical devices with deadly consequences, to ransomware attacks that threaten to shut down hospitals.  Continue Reading HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below, the guidance clarifies important questions about operating in the cloud, including the role of encryption when determining whether a cloud service provider is a business associate. Continue Reading HHS Publishes Guidance on HIPAA and Cloud Computing

On July 12, 2016, HHS’s Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program.

For those looking to catch up on the Phase II audits, we provided readers with an overview of the audits back in March. In April, we discussed the HIPAA Audit Protocol that OCR is using to conduct the Phase II audits.  And in May, we alerted readers to the notifications that OCR was e-mailing to covered entities in an effort to verify their contact information.

In its latest e-mail, OCR confirms that notification letters were delivered on Monday, July 11, 2016, to 167 health plans, health care providers and health care clearinghouses notifying them of their inclusion in the desk audit portion of the audit program. The desk audits will examine the selected entities’ compliance with HIPAA’s Privacy, Security, and Breach Notification Rules by examining certain documentation that the entities are required to maintain under HIPAA. OCR provides the following table setting forth the subject matter of the documentation review:

HIPAA Desk AuditNotably, the three areas covered under the Privacy Rule relate to how patients are made aware of their rights under HIPAA and how they can access their own medical records.  The desk audit does not focus on policies related to uses and disclosure of PHI.  This emphasis dovetails with OCR recent efforts to educate patients and providers about patient access rights (which we previously covered here).

Entities have 10 business days, until July 22, 2016, to respond to the document requests.

OCR separately notes that desk audits of business associates will be occurring this fall. We will continue to follow developments in the Phase II audit program and bring you updates and analysis as they occurs.

Written by: Stephanie D. Willis and Dianne J. Bourque

On March 28, 2014, the Office of Civil Rights (OCR) announced the release of an online and iPad app-based security risk assessment (SRA) tool.  The tool is intended to help health care providers in small to medium sized offices conduct and document risk assessments of their organizations and meet their compliance obligations under the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.  The SRA tool is a self-contained, operating system application that can run on Windows for desktop and laptop computers or Apple’s iOS for iPad.  OCR has imposed penalties based on a provider’s failure to properly perform a risk assessment compliant with the Security Rule’s standards, as we profiled in a recent post.  The release of the tool further signals OCR’s increased focus on preventive measures that covered entities and business associates must undertake to demonstrate awareness of and adherence to HIPAA’s requirements.

Continue Reading Compliance is No Joke: OCR Releases Security Risk Assessment Tool

Written by Kimberly Gold

The recent Office for Civil Rights (OCR) enforcement action against Alaska’s Medicaid program provides insight into OCR’s enforcement approach and timely reminders for covered entities hoping to avoid a similar fate.  In the first settlement of its kind against a state Medicaid agency, Alaska has agreed to pay the U.S. Department of Health and Human Services (HHS) $1,700,000 under a Resolution Agreement to settle alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.  The settlement stems from an investigation by OCR following a breach report by DHSS as required under the Health Information Technology for Economic and Clinical Health (HITECH) Act.

The breach report, submitted by DHSS in 2009, disclosed that a USB hard drive, which may have contained electronic protected health information (ePHI) of Alaska Medicaid beneficiaries, was stolen from a DHSS employee’s car.  The resulting OCR investigation uncovered evidence of inadequate DHHS policies and procedures to safeguard ePHI.  OCR found that DHHS  failed to complete a risk analysis, implement adequate risk management measures, conduct employee security training, implement device and media controls, and address device and media encryption.

What may HIPAA covered entities learn from the Alaska settlement?

  • Seven-figure settlements are becoming more the rule than the exception when OCR finds serious violations.
  • OCR continues to require corrective action plans, which add significantly to a covered entity’s costs resulting from a violation.  The Alaska corrective action plan requires DHSS to properly safeguard the ePHI of its Medicaid beneficiaries, and to designate an independent monitor to regularly report to OCR on the state’s efforts to ensure compliance.
  • OCR is not afraid to go after a state agency.  In a press release, OCR Director Leon Rodriguez stated: “This is OCR’s first HIPAA enforcement action against a state agency and we expect organizations to comply with their obligations under these rules regardless of whether they are private or public entities.”
  • The settlement also illustrates the priority that OCR is placing on enforcement of HIPAA violations involving stolen devices.  Mr. Rodriguez noted that “[c]overed entities must perform a full and comprehensive risk assessment and have in place meaningful access controls to safeguard hardware and portable devices.”