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FTC Issues Final Rule to Expand Scope of the Health Breach …

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates. We previously covered the proposed rule, which was issued on May 18, 2023.

Actived: 4 days ago

URL: https://www.covingtondigitalhealth.com/2024/05/ftc-issues-final-rule-to-expand-scope-of-the-health-breach-notification-rule/

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WEBIn early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a …

Category: Health Go Health

HHS Publishes Final Rule to Align Part 2 and HIPAA

WEBOn February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) …

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EFPIA Issues Statement on Application of the AI Act in the …

WEBWith over 250 lawyers actively practicing in our Health Care and Life Sciences groups, across multiple disciplines and geographies, we offer one of the …

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MHRA Outlines New Strategic Approach to Artificial Intelligence

WEBOn April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence …

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FTC and HHS Announce Updated Health Privacy Publication

WEBAnna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her …

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CMS Proposal Would Impact Coverage of Innovative Digital Health

WEBDigital health technologies that are eligible for breakthrough designation and fall within a Medicare benefit category would have been eligible for the MCIT pathway. In …

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HHS Proposes Rule to Improve Standards for Electronic …

WEBOn December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain …

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FDA Seeks Comments on Agency Actions to Advance …

WEBOn March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a …

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California Enacts Amendments to the CMIA Covington Digital …

WEBOn September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act …

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FDA Releases Draft Guidance on Electronic Systems, Records, and

WEBOn March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and …

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EHDS Series – 3: The European Health Data Space from the Health …

WEBWhen health data users receive access in the HDAB’s secure processing environment to pseudonymized health data, subject to the GDPR, they qualify as data …

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California AG Probes for Potential Bias in Healthcare Algorithms

WEBDigital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with …

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5 Reasons Digital Solutions for Women+ Health Will Grow in 2023

WEBDigital solutions for women+ health can also help address social stigma and legal hurdles for the delivery of care, for example with telemedicine consultations on …

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HHS Launches New “Health Apps” Website to Highlight HIPAA …

WEBAnna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her …

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FDA Releases Discussion Paper on AI in the Drug and Biological …

WEBFor a summary and analysis of FDA’s first discussion paper, which focused on the use of AI in drug manufacturing, please see our prior blog post, “FDA Seeks …

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EHDS Series – 5: European Health Data Space Governance, …

WEBrevoke a health data user’s permit and exclude a data user from EHDS for up to five years; fine a data holder who refuses to share data, with periodic penalty …

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The Potential Benefits of Digital Health Technology in Managing …

WEBDigital health technology can help manage the pandemic by providing an early signal to potential infection. As widely reported, many public health authorities are …

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FDA Medical Product Centers Continue Focus on AI Covington …

WEBOlivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health …

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M.D. Anderson Wins Appeal Over $4.3 Million HIPAA Penalty

WEBOn January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of …

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Are Wearables Medical Devices Requiring a CE-Mark in the EU

WEBUnder the MDD, medical devices manufacturers are subject to various regulatory obligations. In particular, the MDD requires (among other things) that a CE …

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