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Cybersecurity › Digital Health

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... more +
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 -
Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Orrick, Herrington & Sutcliffe LLP

Privacy and Security Considerations of Mounting the “21st Century Healthcare Experience” Promised by the CMS HealthTech Ecosystem

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At a recent “Make HealthTech Great Again” event, the White House and the Centers for Medicare and Medicaid Services (CMS) announced the launch of a digital health technology ecosystem in partnership with private sector...more

Morgan Lewis - As Prescribed

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

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The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more

Cranfill Sumner LLP

Healthcare M&A in 2025: Key Legal and Strategic Insights

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The healthcare mergers and acquisitions (M&A) landscape is evolving rapidly, driven by factors such as value-based care, private equity, digital health, and labor shortages. In this article, we explore the key legal and...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Foley & Lardner LLP

HIPAA Risk Analyses for Digital Health: Navigating AI, M&A and Vendor Diligence

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Share on Twitter Share by Email Share Back to top HIPAA Security Risk Analyses (SRAs) should be the foundation of every digital health company’s cybersecurity compliance. Far more than a checkbox exercise, a comprehensive SRA...more

Ropes & Gray LLP

Glow Up or Sell Out? Opportunities and Risks in the Consumer Health and Beauty Sector

Ropes & Gray LLP on

The global M&A market is forever evolving, and nowhere is this truer than in beauty, which has recently seen a notable surge in growth and popularity. McKinsey forecasts global beauty sales to grow six percent annually until...more

McDermott Will & Schulte

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2025 #3

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News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #3

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News Briefs - Joint Employer Rule Withdrawn by National Labor Relations Board - The National Labor Relations Board withdrew its appeal of a district court ruling that enjoined its "joint employer" final rule....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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - June 2024 #1

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News Briefs - Hospital Lobbies Join Attempt to Delay Noncompete Ban -Hospital lobbies have signed on to a multisector letter of 230 industry associations and chambers of commerce urging the Federal Trade Commission to bump...more

BakerHostetler

FTC Continues Focus on Disclosure of Health Information to Third-Party Technologies

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A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Health Care Compliance Association (HCCA) on

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - March 2024 #4

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News Briefs - Lawmaker Introduces Health Care Cybersecurity Improvement Act - Senator Mark Warner (D-VA) has introduced the Health Care Cybersecurity Improvement Act of 2024, which would allow for advance and accelerated...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

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

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Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Health Care Compliance Association (HCCA) on

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2024 #2

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News Briefs - DOL Independent Contractor Rule Likely to Be Burden for SNFs - Many skilled nursing operators will need to reclassify their existing relationships with independent contractors and rethink future ones in the wake...more

Barnea Jaffa Lande & Co.

Israel Innovation Authority Funds Proof of Concept

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As part of its activities promoting entrepreneurship and innovation in Israel, the Israel Innovation Authority (IIA) provides budgets to technology entrepreneurship projects to encourage and support their various stages,...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2023 #3

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News Briefs - FTC Aims to Take Action on Non-Competes, M&A Enforcement - Healthcare lobbying organizations' efforts to carve out industry-specific exemptions in recently proposed Federal Trade Commission policies are...more

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