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Health System Cybersecurity Risks: Part Two

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving...more

Health System Cybersecurity Risks: Part One

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving...more

The Countdown to Complete Your Consumer Health Data Privacy Policy Under the Washington My Health My Data Act

Almost one year ago, Washington State passed the “My Health, My Data” Act (the Act), which aims to protect Washington consumer health data, particularly data related to reproductive healthcare. The Act is the first law in the...more

Litigation Minute: Pixel Tools in the Health Care Arena (Pixel Tool Litigation Series: Part Four of Four)

What You Need to Know in a Minute or Less - The use of pixel technologies on websites and mobile apps in the health care field has garnered considerable attention from regulators and the plaintiffs’ class action bar....more

"My Health, My Data" Is First of Its Kind Privacy Law Focused on Protecting Consumer Health Data

SUMMARY - On 27 April 2023, Washington Gov. Inslee signed into law House Bill 1155, referred to as the “My Health, My Data” Act (the Act), which takes effect on 31 March 2024. The Act aims to protect Washington consumer...more

HHS Proposes Heightened Protections for "Highly Sensitive" PHI Related Reproductive Health Care in the Wake of Dobbs

SUMMARY - The US Department of Health and Human Services’ Office for Civil Rights (HHS) is proposing changes to the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). HHS's proposed changes...more

Confidentiality of Substance Use Disorder Records: Long-awaited NPRM Proposes Aligning Part 2 with HIPAA

BACKGROUND - As we noted in prior health care alerts in 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) significantly overhauled the federal law that governs the confidentiality of substance use...more

Privacy of Health Information After Dobbs: OCR Guidance on Disclosures of PHI and the Privacy of Personal Information on Devices

On 28 June 2022, in the wake of the U.S. Supreme Court’s ruling in Dobbs vs. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra directed the Office for Civil...more

Health Care Triage: Data Security Breaches in the Health Care Sector

Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care sector. They define what qualifies under HIPAA as a protected health...more

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part IV: Other Potential Applicable Laws

This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part II: HIPAA (Continued) & Additional...

In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part I: HIPAA

Digital health technologies are revolutionizing the global health environment by advancing healthcare services, Big Data analytics and medical device development and innovation, expanding the reach, accessibility and...more

Health Care Triage: Cybersecurity Risk in the Health Care Industry

As health care providers are increasingly relying on complex and integrated electronic medical record systems, the health care industry has rapidly become one of the most frequent and often vulnerable targets for...more

The Practitioner's Guide to SAMHSA's 2020 Final Part 2 Rules - More Changes on the Horizon

As we previously reported, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) overhauled 42 U.S.C. §290dd–2, commonly referred to as “part 2.” Part 2 regulates the confidentiality of substance use disorder...more

What Comes Next for Part 2? The CARES Act’s Surprising Overhaul of the Controversial Law Protecting the Confidentiality of...

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), [1] signed into law March 27, 2020, significantly overhauls the federal law that governs the confidentiality of substance use disorder (“SUD”) records at...more

SAMHSA’s Balancing Act in Its 2019 Proposed Rulemaking: Weighing the Benefits of Enhanced Technology Against the Risks of Breach -...

For the third time in as many years, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) has proposed revisions to the Confidentiality of Substance Use Disorder Patient Records regulations at 42 C.F.R....more

Disclosure of Substance Use Disorder Records Enters the 21st Century: SAMHSA Proposes Changes to Part 2, But Do They Go Far...

Background - As many health care practitioners, health information management professionals, and health lawyers know, balancing patients’ privacy interests with the need to access accurate, up-to-date medical information can...more

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