Category

HHS

02 October 2019

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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30 April 2019

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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14 February 2019

Health Sector Council Released Cybersecurity Recommendations for Medical Devices and Health IT

On January 28, 2019, the Healthcare and Public Health Sector Coordinating Council released the “Medical Device and Health IT Joint Security Plan” (“JSP” or “Plan”)—cybersecurity recommendations for medical device manufacturers, healthcare information technology vendors, and healthcare providers.  U.S. Government entities, including the FDA, participated in the development of the Plan.   The JSP comes close on the heels of the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” a similar effort by a public-private partnership to provide cybersecurity guidance to healthcare industry stakeholders. (more…)

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08 January 2019

HHS Releases Cybersecurity Guidance for Healthcare Organizations

On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP), is the result of a government and industry collaboration mandated by the Cybersecurity Act of 2015. The HICP is not limited to individually identifiable health information but instead covers organizations’ enterprise-level information security more generally. HHS describes the publication as “practical, understandable, implementable, industry-led, and consensus-based voluntary cybersecurity guidelines to cost-effectively reduce cybersecurity risks for healthcare organizations of varying sizes.” Notwithstanding their voluntary nature, these HHS-backed cybersecurity recommendations are likely to serve as an important reference point for the industry. (more…)

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14 December 2018

HHS Requests Feedback on HIPAA Changes Designed to Improve Care Coordination

On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve Coordinated Care.” The RFI seeks public input on a broad range of potential reforms to Health Insurance Portability and Accountability Act (HIPAA) regulations with a focus on enhancing care coordination. Though only a preliminary step on the path to potential regulatory reform, the RFI’s scope is significant, as is the opportunity it affords stakeholders interested in sharing early input as HHS considers reforms to key health information privacy requirements. (more…)

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19 November 2018

Proposed Changes to Federal Health Privacy Regulations Now at OMB for Review

The Administration is preparing to release a Request for Information (“RFI”) on potential modifications to Health Insurance Portability and Accountability Act (HIPAA) rules.  The draft RFI was recently submitted by the Department of Health and Human Services (“HHS”) to the White House’s Office of Management and Budget (“OMB”) for pre-release review.

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12 October 2018

Three Boston-Area Hospitals Settle HIPAA Allegations Arising From On-Site Filming of Television Documentary

Three Boston-area hospitals collectively paid just under $1 million to settle allegations that they violated HIPAA by improperly disclosing patients’ identities and other protected health information during onsite filming of a television network documentary.  According to the Department of Health and Human Services Office for Civil Rights (OCR)’s September 20, 2018 press release, the three hospitals – Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH) – permitted film crews to film an ABC television network documentary series on premises without first obtaining authorizations from patients.  Collectively, the three hospitals paid $999,000 to settle potential violations of the HIPAA Privacy Rule, with BMC paying $100,000, BWH paying $384,000, and MGH paying $515,000.

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