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Wilson Sonsini Goodrich & Rosati

CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data

During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2025

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The healthcare mergers and acquisitions (M&A) market remained active in Q2 2025, with several sectors including physician practice management (PPM), clinical research, and digital health experiencing continued investment and...more

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

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On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

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The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Epstein Becker & Green

Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care

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One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how...more

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

In Wake of Healthcare System Cyberattack, 22 State Attorneys General Call for Further Action of Data Privacy

On April 25, 2024, the attorneys general of 22 states issued a letter encouraging UnitedHealth Group and its subsidiary, Change Healthcare, to take additional steps to respond to a massively disruptive cyberattack. The broad,...more

Morrison & Foerster LLP

Artificial Intelligence in Healthcare: New Avenues for Liability

Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more

Constangy, Brooks, Smith & Prophete, LLP

New Jersey enacts comprehensive privacy law

On January 16, Gov. Phil Murphy (D) of New Jersey signed Senate Bill No. 332 into law. The New Jersey privacy law generally follows the same framework found in many of the comprehensive privacy laws enacted by other states...more

Fox Rothschild LLP

Groundbreaking U.S. Artificial Intelligence (AI) Rule May Mean A Healthier New Year In 2025 and Beyond

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Exactly 12 days before Christmas, the U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) gave the health industry a unique gift buried in a 900+ page rule adoption. The gift? The first...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

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After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2023

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The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more

Akerman LLP - Health Law Rx

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement...more

Polsinelli

Proposed Regulatory Oversight on the Emerging Use of Artificial Intelligence in Digital Health

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Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 1. Privacy Briefs: January 2023

Report on Patient Privacy Volume 23, no 1 (January 2023) The Centers for Medicare & Medicaid Services (CMS) said a data breach at a Medicare subcontractor impacted the personally identifiable information and protected...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Hanzo

HIPAA Compliance & the Role of Enterprise Information Archiving

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Most people have heard of the Health Insurance Portability and Accountability Act (HIPAA), so it’s not surprising that companies dealing with digital health information will have to be HIPAA compliant. To do so, any protected...more

Health Care Compliance Association (HCCA)

Patient information access automated with the Cures Act

Compliance Today (May 2022) - United States healthcare professionals and patients stand upon the cusp of unprecedented, burdensome regulatory changes that will affect automation and how we manage access to patient...more

Bass, Berry & Sims PLC

Healthcare Transactions Q1 2022

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2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more

Morgan Lewis

Digital Health Trends to Watch in 2022

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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

Rivkin Radler LLP

EyeMed Fined $600K for 2020 Data Breach

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On January 24, New York Attorney General Letitia James announced a settlement with EyeMed Vision Care LLC based on shortcomings in the company’s data security procedures. The problems were discovered during the state’s...more

Wiley Rein LLP

Wiley Consumer Protection Download (January 24, 2022)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Robinson+Cole Data Privacy + Security Insider

ECRI Names Cybersecurity Attacks as Top Health Technology Hazard for 2022

ECRI has been publishing its annual report of health technology hazards for the past 15 years. According to ECRI’s Device Evaluation group, “the Top 10 Health Technology Hazards list identifies the potential sources of danger...more

Morgan Lewis - Tech & Sourcing

FTC Policy Statement on Health Breach Notification Rule: A Conversation with Reece Hirsch

As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade...more

Smart & Biggar

Health Canada paving the way for more AI/ML medical devices

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Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

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The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

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