News & Analysis as of

Regulatory Reform Digital Health

Sheppard Mullin Richter & Hampton LLP

CMS Administrator Outlines His Vision for CMS at NFP Healthcare Investors Conference

The Administrator for the Centers for Medicare & Medicaid Services (CMS), Dr. Mehmet Oz, spoke to non-profit health system executives, investors, and industry observers this week at the 25th Annual Not-for-Profit Healthcare...more

Fenwick & West LLP

CMS Seeks Public Input to Modernize the Digital Health Ecosystem for Medicare Beneficiaries

Fenwick & West LLP on

The Centers for Medicare & Medicaid Services (CMS) has issued a new Request for Information (RFI) aimed at transforming how digital health tools serve Medicare beneficiaries....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

Benesch

Dental/DSO Intelligence Monthly Report: January 2025

Benesch on

Moving into 2025, the dental industry faces a series of transformative shifts driven by evolving patient expectations, the rise of Dental Support Organizations (DSOs) and persistent operational challenges. The industry will...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

McDermott+

CMS Hosts Health Equity Conference: Key Insights and Perspectives

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) held the second annual CMS Health Equity Conference. The event drew several hundred in-person attendees, including my colleague Kayla Holgash, and thousands of...more

Sheppard Mullin Richter & Hampton LLP

Remote Patient Monitoring Innovating Health Tech: A Discussion with Dr. Vipul Kella

The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a...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

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDermott Will & Emery

Trending in Telehealth: December 21, 2023 – January 3, 2024

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

Ankura

Emerging Trends in Healthcare Mergers & Acquisition

Ankura on

The healthcare industry is no stranger to mergers and acquisitions (M&A). Over the years, consolidation has played a significant role in reshaping the healthcare landscape, driven by factors such as regulatory changes,...more

Nelson Mullins Riley & Scarborough LLP

FTC Proposes to Vastly Expand the Health Breach Notification Rule

The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

McDermott Will & Emery

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

McDermott Will & Emery

Digital Health Opportunities Under Federal Fraud and Abuse Regulatory Reform

The US Department of Health and Humans Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) have launched the Regulatory Sprint to Coordinated Care, a reform effort that will address several key health care...more

Jones Day

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

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