Regulatory & Compliance

FDA, CMS Pilot Fast-Tracks Health Tech for Medicare
Regulatory & Compliance FDA, CMS Pilot Fast-Tracks Health Tech for Medicare

A New Era of Regulatory Synergy in Digital Health The U.S. healthcare landscape is on the verge of a significant transformation as the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) launch a pioneering joint pilot program. This initiative is designed to

Disability Groups Sue to Block Delaware's End-of-Life Law
Regulatory & Compliance Disability Groups Sue to Block Delaware's End-of-Life Law

A new Delaware law intended to offer compassionate end-of-life choices to the terminally ill has instead ignited a fierce legal battle, pitting the principle of personal autonomy against the fundamental civil rights of people with disabilities. A coalition of prominent patient and disability

Is This the Answer to Healthcare's Cyber Crisis?
Regulatory & Compliance Is This the Answer to Healthcare's Cyber Crisis?

The American healthcare system is facing a digital siege, a reality starkly illustrated by a devastating 2024 during which over 730 major health data breaches exposed the sensitive information of an unprecedented 270 million people. This escalating crisis reached its catastrophic apex with the

FDA Drug Chief's Sudden Retirement Sparks Industry Fears
Regulatory & Compliance FDA Drug Chief's Sudden Retirement Sparks Industry Fears

The pharmaceutical and biotech sectors are grappling with profound uncertainty following the announcement that Richard Pazdur, a revered Food and Drug Administration veteran, has submitted retirement paperwork just weeks after his appointment to lead the agency's most powerful drug review office.

When Does a Wellness Wearable Become a Medical Device?
Regulatory & Compliance When Does a Wellness Wearable Become a Medical Device?

The sophisticated piece of technology strapped to your wrist is no longer just a step counter or a sleep tracker; it is evolving into a powerful health monitor capable of collecting complex physiological data that once required a visit to a doctor's office. This rapid technological advancement has

Why Is UK Healthcare a Top Target for Ransomware?
Regulatory & Compliance Why Is UK Healthcare a Top Target for Ransomware?

The United Kingdom's healthcare sector is facing an escalating crisis as sophisticated cybercriminals increasingly turn their attention to the vast and sensitive data repositories held by National Health Service (NHS) trusts. A recent, significant data breach at Barts Health NHS Trust, orchestrated

Loading

Subscribe to our weekly news digest.

Join now and become a part of our fast-growing community.

Invalid Email Address
Thanks for Subscribing!
We'll be sending you our best soon!
Something went wrong, please try again later