Expanded Information Block Rules Go into Effect
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
The New Information Blocking Rule: What It Means For Hospices
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release;...more
HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...more
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) software. The January 2026 guidance supersedes the previous, and less detailed,...more
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance)....more
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low Risk Devices" (General...more
On December 29, 2025, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
The 21st Century Cures Act (“Cures Act”) required states to adopt electronic visit verification (EVV) systems for Medicaid-covered personal care services (“PCS”) by January 1, 2020 and for home health care services (“HHCS”)...more
“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational Drugs for Treatment Use:...more
On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the third guidance in a...more
Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more
In a September 3 Press Release, the U.S. Department of Health and Human Services (HHS) announced that it is increasing efforts to curb information blocking. This was quickly followed by a September 4 Enforcement Alert issued...more
Federal enforcement of information blocking rules has entered a new era. On September 3, the US Department of Health and Human Services (HHS) issued a press release announcing a “crackdown” on the “harmful practice” of...more
The US Department of Health and Human Services (HHS) announced, on September 3, 2025, a major enforcement initiative targeting “information blocking” – the practice of restricting access, exchange, or use of electronic health...more
On September 3, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS would increase resources to enforce the information blocking prohibition under the 21st Century Cures Act. Generally, the...more
In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more
The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more
The White House announced it is launching a health data tracking system early next year that involves an unprecedented partnership between the federal government, providers, payors, and private sector technology companies....more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
On April 23, 2025, the US Court of Appeals for the Fourth Circuit denied PointClickCare Technologies, Inc.’s petition for en banc review in Real Time Medical Systems, LLC v. PointClickCare. A Fourth Circuit panel previously...more
The Mental Health Parity and Addiction Equity Act (“MHPAEA”) and its implementing rules require group health plans to ensure that financial requirements (e.g., co-pays, deductibles, and coinsurance), quantitative treatment...more
This week on the American Bar Association’s Our Curious Amalgam podcast, co-hosts Jeny Maier, Managing Partner at Axinn, Veltrop & Harkrider, and Matt Tabas, Antitrust & Competition Partner at Arnold & Porter, are joined by...more