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Data Protection Digital Health

McDermott Will & Emery

European Health Data Space Regulation enters into force

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March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

Wiley Rein LLP

What to Expect from New FTC Leadership on Digital Health Care

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Digital health care companies have navigated a wave of new developments at the Federal Trade Commission (FTC) over the past few years. With new leadership in the Trump Administration, the FTC may be poised to change some of...more

Sheppard Mullin Richter & Hampton LLP

New York’s Health Information Privacy Act: A Turning Point for Digital Health or a Roadblock to Innovation?

The proposed New York Health Information Privacy Act (NYHIPA), currently awaiting Governor Kathy Hochul’s signature, represents a major step in the state’s approach to protecting personal health data in the digital age. At...more

Hogan Lovells

Council of Europe approves the European Health Data Space: a shift towards the digital regulation of health data across the EU

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The Council of Europe has formally adopted the EHDS, marking a significant milestone in the development of a unified framework for health data exchange across Member States. This initiative aims to enhance healthcare...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Hogan Lovells

EU moves closer to a unified digital health system with the European Health Data Space Regulation (EHDS)

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The European Health Data Space (EHDS) Regulation seeks to overcome significant obstacles in digital health by creating a comprehensive framework for sharing electronic health data. It aims to establish clear rules, common...more

Wilson Sonsini Goodrich & Rosati

FTC Final Rule Officially Broadens Health Breach Notification Rule, Targets Health and Wellness Apps

On April 26, 2024, the Federal Trade Commission (FTC) announced a Final Rule that amends the Health Breach Notification Rule (HBNR or Rule) to significantly broaden the FTC’s enforcement power in the area of digital health....more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Seyfarth Shaw LLP

Keeping with the Times - FTC Expands Scope of Health Breach Notification Rule, Even as HHS Announces Its Own HIPAA Update

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On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...more

Wilson Sonsini Goodrich & Rosati

FTC Announces Proposed Settlement Agreements with Two Digital Health Companies for Disclosing Consumers’ Health Information to...

The Federal Trade Commission (FTC) recently announced two proposed settlement agreements (in the form of a stipulated order) (the “consent orders”) with Monument, Inc., an alcohol addiction treatment service, and Cerebral,...more

Foley Hoag LLP - Security, Privacy and the...

FTC's Updated Health Data Breach Rule Covers Apps, Other New Tech

The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Hogan Lovells

Creation of a Health Data Agency in Belgium – A key agency for the future European Health Data Space

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On January 17th, 2024, Belgium welcomed the official launch of the Belgian Health Data Agency. This Agency aims to enhance the availability and utilisation of health data and healthcare data with the objective to drive...more

Sheppard Mullin Richter & Hampton LLP

AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

Expansion of AI in Healthcare - At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more

J.S. Held

Inside the Healthcare Industry: Understanding Emerging Data Privacy & Security Risks and Regulations

J.S. Held on

According to the Theft Resource Center and its 2022 data breach reports, data privacy and security threats are impacting all aspects of the healthcare industry – from providers to payers to medical device companies to...more

Perkins Coie

The New Health Privacy Landscape—Out of the Frying Pan and Into the Fire

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Just a few years ago, the legal landscape governing health-related personal information was relatively simple: Protected Health Information (PHI) was regulated under Health Insurance Portability and Accountability Act...more

McDermott Will & Emery

Digital Health 101: OCR Issues Resources to Educate Patients on Telehealth, PHI

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On October 18, 2023, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) issued two resource documents to help explain the privacy and security risks to patients’ protected health...more

Arnall Golden Gregory LLP

Comment Deadline Approaching: Health Breach Notification Rule

Summary - On May 18, 2023, the Federal Trade Commission (“FTC”) announced a Notice of Proposed Rulemaking (the “Proposed Rule”), which both clarifies the scope of the Health Breach Notification Rule (“HBN Rule”) to include...more

Nelson Mullins Riley & Scarborough LLP

FTC Proposes to Vastly Expand the Health Breach Notification Rule

The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile...more

Sheppard Mullin Richter & Hampton LLP

FTC Proposes Changes to Health Breach Notification Rule Clarifying Application to Health and Wellness Apps

In May, the Federal Trade Commission (“FTC”) proposed changes (the “Proposed Rule”) to the Health Breach Notification Rule (the “Rule”), which, among other items, emphasize that the Rule applies to mobile health applications...more

Sheppard Mullin Richter & Hampton LLP

FTC Looks to Update Health Breach Notification Rule, Targeting Digital Health Industry

The FTC recently proposed amendments to the Health Breach Notification Rule (HBNR). This is on trend with its aggressive interest over the last couple of years in health data not covered by HIPAA....more

McDermott Will & Emery

In Case You Missed It: Highlights | When Digital and Life Sciences Intersect

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In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...more

Bradley Arant Boult Cummings LLP

New Florida Law Will Ban Offshoring of Certain Patient Data

Effective July 1, 2023, a new Florida law will limit certain health care providers from storing patient information offshore. CS/CS/SB 264 (Chapter 2023-33, Laws of Florida), amends the Florida Electronic Health Records...more

Orrick, Herrington & Sutcliffe LLP

6 Things to Know About Washington’s My Health My Data Law

The state of Washington recently enacted My Health My Data (“MHMD”), a game-changing new consumer privacy law focused on health data. MHMD establishes an expansive notice and consent regime for consumer health data with...more

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