Weekly feed
14 curated updates · reviewed against primary sources
The 2026 HHS rule change removes disparate impact analysis from Title VI enforcement, potentially weakening protection against policies that disproportionately harm racial and ethnic minorities in healthcare. The Department of Health and Human Services (HHS) issued a final rule in October 2026...
Tech leaders are using a government-run CMS Slack channel to advocate for consumer adoption of health data apps under the Trump administration. A Slack workspace administered by the Centers for Medicare & Medicaid Services (CMS) has become a central hub for AI and technology industry leaders to...
CMS proposes allowing virtual access to CLIA certificate data (except cytology) and digital image use in gynecologic cytology proficiency testing to address workforce shortages and modernize lab oversight. The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to amend the...
Health-ISAC urges healthcare organizations to define validation processes for restored clinical systems, noting that bringing systems online does not ensure clinician-safe reliance. Health-ISAC published an after-action report on October 5, 2026, detailing findings from its June 24 Americas Hobby...
FDA signals upcoming AI/ML regulatory framework updates slated for 2027 as healthcare technology adoption accelerates The FDA has outlined its plans for issuing new artificial intelligence and machine learning guidance documents in 2027, according to reporting by STAT+.
The final rule enhances price transparency reporting by standardizing machine-readable files with new contextual data, adjusting reporting frequency, and expanding access methods for consumers. The Departments of Health and Human Services, Treasury, and Labor issued a final rule updating the...
iRhythm Technologies is notifying individuals affected by a June 2026 hacking incident involving its wearable cardiac monitoring systems, providing details on the breach scope and response actions. iRhythm Technologies is notifying individuals affected by a hacking incident that occurred in June...
HRSA requests public feedback on its revised information collection request for the Organ Procurement and Transplantation Network data system before OMB review concludes. The Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of...
A practical webinar addresses common uncertainties about HIPAA Security Risk Assessments, aiming to close compliance gaps for healthcare organizations. The HIPAA Journal announced a free webinar titled "A Practical Guide to a HIPAA Security Risk Assessment," hosted by Steve Alder.
Updated federal price transparency requirements effective January 2026 show inconsistent hospital compliance, complicating price comparisons for patients and payers. Hospitals are reporting prices under updated federal hospital price transparency requirements that took effect in January 2026, but...
Utah's health AI sandbox may allow testing of AI tools without FDA oversight, creating potential conflicts between state innovation programs and federal medical device regulations. Utah's regulatory sandbox for health AI technologies allows companies to test AI applications without meeting...
FTC enforcement action highlights growing regulatory focus on healthcare price transparency requirements across major provider organizations. The Federal Trade Commission issued warning letters to 24 major healthcare organizations regarding concerns about inadequate price transparency practices.
FDA will hold a hybrid public meeting and accept written comments through November 25, 2026, on recommendations to reauthorize the Biosimilar User Fee Act before its current authority expires in September 2027. The Food and Drug Administration (FDA) announced a hybrid public meeting to discuss...
FDA's determination of the regulatory review period for Andembry enables patent term restoration under the Hatch-Waxman Act, directly impacting commercial exclusivity for this biological product. The Food and Drug Administration (FDA) has determined the regulatory review period for Andembry, a...