HHS Office for Civil Rights Releases Webinar on Recognized Security Practices: Provides Guidance on Mitigating Potential Violations of HIPAA

Pursuant to legislation passed in 2021, covered entities and business associates subject to HIPAA and facing potential regulatory enforcement may receive some credit lessening to reduce enforcement penalties if they had implemented Recognized Security Practices (RSPs) within the prior 12 months.  However, what may constitute RSPs and how a covered entity or business associate can demonstrate implementation of RSPs to receive such credit had not been clear.  Now, the Department of Health and Human Services is seeking to provide clarity. (more…)

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Digital Health Industry Take Note: New HIPAA Comment Opportunity and Guidance Addresses Growing Risk of Cybersecurity Attacks

Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released a request for information (RFI) seeking input on (1) how covered entities implement recognized security practices, which OCR considers in enforcement matters and (2) the different types of harm that individuals experience from HIPAA violations in order to consider how OCR may share enforcement recoveries with individuals harmed. Digital health companies subject to HIPAA should consider submitting comments by the June deadline to ensure that the evolving digital health industry has a voice in establishing industry best practices and advocating for continued flexibility in the implementation of security standards that suit their unique business needs distinct from traditional covered entities and business associates. (more…)

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Using Data De-Identification to Protect Companies

Many companies hope to benefit from amassing large amounts of data by mining it for market insights, creating internal business models, and supporting strategic, data-driven decisions. But as companies collect and store increasingly enormous volumes of data, they may unknowingly take on significant legal risks, including potential violations of data privacy laws and increased exposure to U.S. litigation discovery obligations. One way that businesses can mitigate these risks is to de-identify the data they collect and store.

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HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule

On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, HIPAA).  HHS stated that the Proposed Rule is intended to reduce burdens that may limit or discourage care coordination and case management communications among individuals and HIPAA-covered entities while continuing to protect the privacy of individuals.  The proposed changes are designed to lead to increased data access, sharing, and portability and to further HHS’s emphasis on patients’ right of information access, which has been highlighted through a series of enforcement actions in 2020.  If enacted as proposed, the amendments would require healthcare providers and electronic health records (EHR) vendors to update policies and disclosures related to information access and perhaps even to redesign certain EHR processes.  Comments are due 60 days after publication in the Federal Register.

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OCR 2020 Settlements Target HIPAA Security Rule Non-Compliance

In almost the first three quarters of 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) has settled three cases related to alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”), totaling $1,165,000.  These settlements underscore OCR’s continued focus on enforcement of the HIPAA Security Rule.

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SAMHSA Releases Final 42 CFR Part 2 Revised Rule

On July 13, the Department of Health and Human Services’ Substance Abuse and Mental Health Services (“SAMHSA”) announced final revisions to the Confidentiality of Substance Use Disorder Patient Records regulation codified at 42 CFR Part 2 (so-called “Part 2” regulations).  These regulations—which apply to certain information relating to patients being treated for substance use disorders (“SUDs”)—impose restrictions above and beyond those in the Health Insurance Portability and Accountability Act (“HIPAA”).  While the final rule does not fundamentally change the basic requirements of the Part 2 regulations, it relaxes some of the restrictions the regulations impose on holders of Part 2 information, in particular, to facilitate care coordination.

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HHS Issues Limited Waiver of Certain HIPAA Privacy Rule Obligations and Exercises Enforcement Discretion with Respect to Telehealth Services In Light of COVID Public Health Emergency

This week the U.S. Department of Health and Human Services (HHS) took action to waive penalties and refrain from enforcing certain federal health information privacy restrictions under the Health Insurance Portability and Accountability Act (HIPAA) in response to COVID-19.

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Part 2 Proposed Rule Seeks to Reduce Barriers to Coordination of Care for Substance Use Disorders

In an effort to reduce barriers to coordination of care, the U.S. Department of Health and Human Services (“HHS”) is considering changes to Federal restrictions on the sharing of substance use disorder (“SUD”) records.  The proposed changes would modify 42 C.F.R. Part 2 (“Part 2”) regulations that place restrictive conditions on the disclosure of SUD patient records—limitations that go above and beyond Health Insurance Portability and Accountability Act (“HIPAA”) restrictions.

The barriers imposed by these rules—which have been in place since the 1970s—have become the focus of particular attention in light of the opioid crisis, as members of Congress and other stakeholders have raised concerns about how the Part 2 statute and implementing regulations may inhibit efforts to respond and coordinate care.  Members of Congress have called for reform, but have been unsuccessful at seeking legislative fixes thus far.

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OCR Reduces HIPAA Penalties and Clarifies Liability for Transferring ePHI to Third-Party Health Apps

New Annual HIPAA Penalty Tiers

Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) has announced that it is exercising its enforcement discretion to lower maximum annual HIPAA penalties.

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First Multistate HIPAA Data Breach Lawsuit May Signal Increased State Interest in Data Security Enforcement

On December 3, 2018, twelve attorneys general (“AGs”) jointly filed a data breach lawsuit against Medical Informatics Engineering and its subsidiary, NoMoreClipboard LLC (collectively “the Company”), an electronic health records company, in federal district court in Indiana.  See Indiana v. Med. Informatics Eng’g, Inc., No. 3:18-cv-00969 (N.D. Ind. filed Dec. 3, 2018).  The suit—led by Indiana Attorney General Curtis Hill—is joined by AGs from Arizona, Arkansas, Florida, Iowa, Kansas, Kentucky, Louisiana, Minnesota, Nebraska, North Carolina and Wisconsin.  While state AGs have previously exercised their civil enforcement authorities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this is the first multi-state data breach lawsuit alleging HIPAA violations in federal court and may signal increased interest on the part of state officials in exercising their data protection authorities to address cybersecurity incidents.

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