News & Analysis as of May 5, 2025

Data Protection

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

European Health Data Space Regulation enters into force

McDermott Will & Emery on 3/27/2025

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

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

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

Privacy Briefs: May 2024

Health Care Compliance Association (HCCA) on 5/13/2024

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

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

Skadden, Arps, Slate, Meagher & Flom LLP on 4/4/2024

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

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

Hogan Lovells on 2/28/2024

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

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

J.S. Held on 11/29/2023

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

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

McDermott Will & Emery on 10/25/2023

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

Comment Deadline Approaching: Health Breach Notification Rule

Arnall Golden Gregory LLP on 7/21/2023

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

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

Health Care Compliance Association (HCCA) on 2/16/2023

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

FTC emphasizes expectations around the health breach notification rule

Hogan Lovells on 2/28/2022

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

New Legislation Aims to Upgrade HIPAA to Account for New Healthcare Technologies

Morgan Lewis - Health Law Scan on 2/25/2022

On February 9, 2022, US Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI) introduced bipartisan legislation designed to modernize health privacy laws, including the Health Insurance Portability and Accountability...more

Digital Health Trends to Watch in 2022

Morgan Lewis on 2/25/2022

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

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

K&L Gates LLP on 10/7/2021

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

[Webinar] Protecting the Telehealth Consumer: FTC and State-Based Considerations - June 22nd, 12:00 pm - 1:00 pm EDT

McDermott Will & Emery on 6/14/2021

As the COVID-19 pandemic in the United States is easing, telemedicine is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers...more

Health Datapalooza - February 2020

Morgan Lewis - Health Law Scan on 3/4/2020

Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC. This year, Health Datapalooza was co-located with the National Health Policy Conference, providing attendees with an...more

A HealthIT Cybersecurity Toolkit

Foley Hoag LLP - Security, Privacy and the... on 9/23/2019

A recent report from the Mass Digital Health Council includes a cybersecurity toolkit created by MDHC’s Cybersecurity Group of Experts (CGE). The toolkit will enable faster clinical adoption of new digital health products,...more

2018 Digital Health Data Developments – Navigating Change in 2019

McDermott Will & Emery on 2/5/2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

2018 Digital Health Year in Review: Focus on Data

McDermott Will & Emery on 1/29/2019

Introduction - The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation...more

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on 7/13/2018

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

Financing High-Growth Health IT Companies: McDermott and Capstone’s Panel Recap from HIMSS 18

McDermott Will & Emery on 4/12/2018

Earlier this month, more than 45,000 attendees descended on Las Vegas, NV, for the nation’s largest annual health care technology conference: the 2018 HIMSS Conference & Exhibition (HIMSS18). Conversations and educational...more

Sharing and Mining Patient Data in Digital Health and Telemedicine: Laws You Need to Know

Foley & Lardner LLP on 4/3/2018

The use of new technologies such as digital health applications, telemedicine, and information exchanges can provide game-changing benefits for providers and patients alike. However, with increased sharing comes increased...more

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