HIPAA privacy and security
Healthcare and life sciences organizations face a dual enforcement posture on HIPAA privacy and security right now: the U.S. Department of Health and Human Services Office for Civil Rights continues processing a backlog of breach investigations under the HIPAA Security Rule's technical safeguard requirements, while the U.S. Federal Trade Commission has extended its own authority over health data through the Health Breach Notification Rule, creating overlapping obligations for digital health companies and covered entities alike. The proposed HIPAA Security Rule overhaul published in late 2024 would mandate specific cybersecurity controls, including network segmentation and annual audits, and compliance teams are mapping existing vendor agreements against those draft requirements before a final rule lands.
Watch
- Proposed HIPAA Security Rule amendments: new mandatory technical controls under review
- FTC Health Breach Notification Rule: enforcement actions against non-HIPAA health apps expanding
- OCR right-of-access enforcement: civil monetary penalties issued to smaller covered entities
- State attorneys general HIPAA-parallel actions in California, New York, and Texas
- Business associate agreement gaps flagged in recent OCR resolution agreements
Recent material activity in Healthcare & Life Sciences
A selection of recent published briefs; this is not a complete archive.
FDA issues warning letter and import alert to Indian contract drug manufacturer for records access refusal
FDA's Center for Drug Evaluation and Research issued a warning letter on February 13, 2025, to Zenzi Pharmaceutical Industries Pvt. Ltd. in Maharashtra, India, for refusing to provide records under the foreign records ac…
Read a full sample brief →FDA closes warning letter against Zenzi Pharmaceutical but maintains Import Alert 66-79 over inspection refusal
FDA's Center for Drug Evaluation and Research issued a closeout letter on September 18, 2026 to Zenzi Pharmaceutical Industries Private Limited, a Maharashtra-based drug manufacturer. The firm remains on Import Alert 66-…
Read a full sample brief →FDA approves belzutifan plus lenvatinib combination for advanced clear cell renal cell carcinoma in adults
The FDA approved belzutifan combined with lenvatinib on September 24, 2026, for adults with advanced renal cell carcinoma with a clear cell component. This expands the labeled indications for both agents. The approval es…
Read a full sample brief →Health Canada safety alert flags premature battery drain in Stryker Inzone Detachment System affecting coil delivery function
Health Canada published a safety alert on September 24, 2026 covering Stryker's Inzone Detachment System following observations of premature battery drain. Affected devices may fail to power on, present diminished indica…
Read a full sample brief →FDA Class I recall removes all Abiomed Automated Impella Controllers over purge flag failures linked to 37 injuries and three deaths
The FDA has classified Abiomed's removal of all Automated Impella Controllers as a Class I recall — its most serious designation — following purge flag component failures within the purge pressure sensor assembly. As of …
Read a full sample brief →FDA Class I recall removes all Automated Impella Controllers globally over purge flag failures linked to 37 injuries and three deaths
The FDA has classified Abiomed's removal of all Automated Impella Controllers as a Class I recall — its most serious designation — following purge flag component failures within the purge pressure sensor assembly. As of …
Read a full sample brief →FDA classifies BD convenience kit correction as Class I recall over recalled sodium chloride ampules
The FDA on September 24, 2026 elevated its August 18 Early Alert for Becton Dickinson convenience kits and procedure trays to a Class I recall classification. The kits contain sodium chloride ampules subject to a prior H…
Read a full sample brief →FDA classifies Becton Dickinson convenience kit correction as Class I recall over sterility-compromised sodium chloride ampules
The FDA on September 24, 2026 elevated its August 18 Early Alert for Becton Dickinson convenience kits and procedure trays to a Class I recall classification. The affected kits contain sodium chloride ampules manufacture…
Read a full sample brief →Health Canada Drugs & Medical Devices release pending Cresthaven Analytics full analysis: InterStim™ Systems
Health Canada Drugs & Medical Devices published a regulatory release titled 'InterStim™ Systems'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source link below for the complete primary t…
Read a full sample brief →Baxter issues urgent correction for Likorall ceiling-mounted patient lift systems over double-fault drop risk
Baxter Corporation issued an urgent correction on September 24, 2026 for the Likorall ceiling-mounted patient lift system. The correction targets a double-fault failure scenario in which simultaneous motor shaft breakage…
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