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Digital Health Regulatory Requirements

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

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As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Stikeman Elliott LLP

Ontario’s More Convenient Care Act, 2025: A New Strategy for the Healthcare Sector

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On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...more

Foley & Lardner LLP

The Intersection of AI, Digital Health, and the TCPA: What You Need to Know

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Artificial intelligence (AI) is widely transforming digital health, including by automating certain patient communications. However, as health care companies consider deploying AI-driven chatbots, texting platforms, and...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

A&O Shearman on

On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

Foley & Lardner LLP

HIPAA Compliance for AI in Digital Health: What Privacy Officers Need to Know

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Artificial intelligence (AI) is rapidly reshaping the digital health sector, driving advances in patient engagement, diagnostics, and operational efficiency. However, for Privacy Officers, AI’s integration into digital health...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

Bass, Berry & Sims PLC on

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

Wilson Sonsini Goodrich & Rosati

Utah Enacts Mental Health Chatbot Law

On March 25, 2025, Utah Governor Spencer Cox signed HB 452, which establishes new rules for the use of artificial intelligence (AI) mental health chatbots accessible to any “Utah user,” defined as, “an individual located in...more

Pagefreezer

HIPAA Regulations & Business Associate Agreements In The Age Of Digital Collaboration

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The healthcare industry has come up against unprecedented pressure in recent years. Digital transformation has had a significant role to play when it comes to creating the efficiency needed to deal with the challenges of a...more

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

Epstein Becker & Green

Telehealth Cliff Averted, for Now (But September is Six Months Away)

Epstein Becker & Green on

The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now....more

Ropes & Gray LLP

[Podcast] Women @ RopesTalk: Conversation with Jan Sbarbaro, Lyric

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On this episode of Women @ RopesTalk hosted by IP transactions and licensing partner Megan Baca, IP transactions partner Emily Karlberg returns for another engaging conversation, this time with Jan Sbarbaro, the chief legal &...more

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

McDermott Will & Emery

Five Questions With a Health Lawyer: Stacey L. Callaghan

What is your favorite part about practicing healthcare law at McDermott? My favorite part about practicing healthcare law here at McDermott is the phenomenal team. There are thought leaders in every sub-specialty you can...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

McDermott Will & Emery

Trending in Telehealth: January 6 – 27, 2025

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

Morgan Lewis on

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Foley & Lardner LLP

New York’s Proposed Health Information Privacy Act Takes Aim at Digital Health Companies

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The New York Health Information Privacy Act (NYHIPA), if enacted, could create a chilling effect on patient access and engagement to readily available digital health care services relied upon by New Yorkers. Digital health...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

McDermott Will & Emery

Trending in Telehealth: July 30 – August 12, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Barnea Jaffa Lande & Co.

Femtech in Israel: The Challenges, Opportunities, and Legal Considerations Every Company Needs to Know

The field of women’s health technology (FemTech) is rapidly evolving, and Israel is considered one of the global leaders, ranking fourth worldwide in the number of FemTech companies. Additionally, Israel ranks second in...more

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