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Digital Health Data Privacy Data Protection

McDermott Will & Emery

European Health Data Space Regulation enters into force

McDermott Will & Emery on

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

Wiley Rein LLP on

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

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

Seyfarth Shaw LLP on

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

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

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

Perkins Coie on

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

McDermott Will & Emery on

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

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

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

Sheppard Mullin Richter & Hampton LLP

Washington State Enacts Landmark Privacy Law Aimed at Digital Health Industry

On April 27, 2023, the state of Washington enacted a landmark privacy law aimed at protecting the privacy of health data not covered by HIPAA. This law, named the “My Health My Data Act,” covers a very wide range of entities,...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. Privacy Briefs: February 2023

Report on Patient Privacy Volume 23, no 2 (February 2023) DCH Health Systems, based in Tuscaloosa, Ala., said it fired an employee in December after a routine privacy audit revealed evidence that the worker had accessed some...more

Sheppard Mullin Richter & Hampton LLP

FTC and Other Regulators Continue to Signal Interest in Mobile Health Apps

The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...more

Wilson Sonsini Goodrich & Rosati

Privacy and Security of Health Information: A Primer for Digital Health Companies

COVID-19 has rapidly accelerated our expectations that virtual connection can deliver better and more economical care. As a result, digital health companies have an unprecedented opportunity to innovate, but with that...more

Sheppard Mullin Richter & Hampton LLP

FTC Continues to Signal Interest in Digital Health Industry, Publishing Updated Resources

The FTC recently published two new resources for complying with the Health Breach Notification Rule. The Rule requires vendors of personal health records (PHR), PHR-related entities and service providers to these entities, to...more

Hogan Lovells

FTC emphasizes expectations around the health breach notification rule

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The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more

Sheppard Mullin Richter & Hampton LLP

California Broadens Security and Breach Laws, Includes Genetic Data

California recently updated both its data security and breach notice laws to include genetic data. With the passage of AB 825, the data security law now includes in the definition of “personal information” genetic data. The...more

K&L Gates LLP

Health Care Triage: FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations

K&L Gates LLP on

In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more

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