By

Kate Heinzelman

18 March 2020

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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05 March 2020

Coronavirus Risks – U.S. and European Employment and Privacy Law Issues

This post seeks to help parties navigate issues arising from COVID-19 risks from an employment and privacy law perspective in both the United States and Europe.

Novel coronavirus (COVID-19) presents significant issues for employers to navigate and significant consequences for employees across industries as COVID-19 reduces consumer spending, disrupts supply chains and presents challenges for managing workforces globally. Employers should be aware of their responsibilities and proactively put in place action plans to address this growing problem. Designing these plans, and addressing requested or mandated leaves and other restrictions on employee work, presents myriad employment law issues that may vary by jurisdiction. Employers are also likely to confront privacy questions as they seek information on employees’ and others’ health and travel across jurisdictions. In developing a plan, employers will want to consider these issues in a holistic and coordinated manner.

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12 February 2020

A February 2020 Surprise: California Attorney General Proposes Significant Revisions to CCPA Regulations

Just as companies were starting to recover from their exertions to put in place California Consumer Privacy Act (“CCPA”) compliance programs before the law’s January 1, 2020 entry into force, the California Attorney General (“AG”) provided an early February surprise.  CCPA watchers long expected that the AG would revise the CCPA regulations he initially proposed on October 10, 2019.  But when the AG actually released his proposed regulations on February 7 – a proposal he subsequently modified slightly on February 10 – both the timing and breadth of the revisions were surprising.  In short, the revisions were both sooner and more significant than expected.

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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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03 September 2019

Carpenter and Everything After: The Supreme Court Nudges the Fourth Amendment into the Information Age

*This article was first published by the American Bar Association Infrastructure and Regulated Industries in Summer 2019.

Every year, as the calendar turns to June, the legal community looks to the Supreme Court. Eager to get to the Term’s end, the Justices rush to complete all of the outstanding opinions. Since the most difficult and important cases usually take the longest to work out, they are typically the stragglers. June is thus the time when the “blockbuster” opinions are issued—the cases that law professors analyze in their tenure pieces and that law school students study, quite possibly for years to come.

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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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