On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range
Health Care
Medical: AI Scribes and the legal obligations of doctors.
Thursday 26 March 2026. 5 pm Brisbane time, 6 pm Sydney / Melbourne time.
Link to Register (no cost): Tickets.
Dr Owen Bradfield is presenting When Algorithms Write the Record – AI Scribes and the legal Obligations of doctors for the Australian Centre for Health Law Research (QUT Brisbane or online access).
Precis:
The…
The Future of Healthcare Collaboration Is Intelligent
Healthcare is evolving rapidly—but one challenge remains persistent: finding the right clinical partner. Whether it’s a Nurse Practitioner seeking a collaborating physician or a healthcare organization building a compliant care model, matching the right professionals has traditionally been slow, manual, and inefficient.
Today, machine learning healthcare systems are transforming this process. AI-powered platforms are redefining…
Is WISeR Really Wiser?
If anyone will be at HCCA’s regional conference next week in Alaska, I will be there speaking about e/m changes. Please come say hey if you are there.
My presentation is: “Code Breakers: Navigating Key Changes in CMS Evaluation & Management Services and Coding”
Speaker: Knicole C. Emanuel
Healthcare Compliance: Intermediate
I plan to: 1.…
Shaping the Future: Navigating State-Level AI Legislation in Healthcare
This post is part of our The Top 2025 Privacy and Security Issues Still Shaping Healthcare series, in which our team of attorneys provides essential strategies and insights for healthcare privacy and security.
Innovations in artificial intelligence (AI), including advances in generative AI (GenAI) and machine learning, provide new opportunities for healthcare providers, promising improved efficiency in areas such as medical record keeping and…
FDA Continues to Ease Regulatory Hurdles for Wearable Health Products
The U.S. Food and Drug Administration (FDA) recently updated two guidance documents applicable to wearable devices and guidance for clinical decision support tools, continuing the agency’s efforts to ease regulatory hurdles for digital health tools and potentially the use of artificial intelligence. The updates expand the type of digital health tools, including certain general wellness…
MedTech Collaborations: Structuring for Scale and Exit
Knicole Emanuel to Speak at the AHLA Winter Institute 2026
Raleigh partner Knicole Emanuel will speak at the 2026 Winter Institute: Advising Providers & AI in Health Care Conferences, hosted by the American Health Law Association (AHLA), in Las Vegas on February 11-13. Emanuel will co-present a session titled “AI in Health Care: Navigating Legal Risk and Compliance Obligations,” alongside Leslie Boles, co-owner and president…
Major HIPAA Security Rule Changes on the Horizon: Is Your Healthcare Organization Ready?
This post is part of our The Top 2025 Privacy and Security Issues Still Shaping Healthcare series, in which our team of attorneys provides essential strategies and insights for healthcare privacy and security.
Why Now? The Rising Cyber Threats Driving HIPAA Reform
In December 2024, the U.S. Department of Health and Human Services Office for…
When the Rules Changed: The Top 2025 Privacy and Security Issues Still Shaping Healthcare
The 2025 Top Ten list reflects a regulatory environment in significant transition. Last year’s healthcare privacy and security landscape presented extraordinary challenges for compliance professionals, marked by sweeping regulatory changes on the federal and state level, intensified enforcement activity, and a growing and evolving environment that demanded constant vigilance. The volatile landscape demanded adaptability, careful attention to the regulatory details, and comprehensive compliance programs. The Top Ten list offers a…
