Recordkeeping and document retention
Recordkeeping and document retention in Healthcare & Life Sciences sits under active enforcement pressure from the U.S. Department of Health and Human Services Office for Civil Rights, the U.S. Food and Drug Administration, and the European Medicines Agency, each operating distinct retention schedules, audit trail requirements, and destruction protocols that do not align with one another. FDA's 21 CFR Part 11 requirements for electronic records remain a live audit trigger, and HHS OCR has continued to cite inadequate retention controls in HIPAA enforcement actions. Compliance teams managing multi-jurisdictional operations are reconciling these obligations now, not waiting for the next audit cycle.
Watch
- FDA 21 CFR Part 11 audit trail gaps cited in recent device and pharma inspections
- HHS OCR HIPAA enforcement pattern: retention failures tied to breach investigations
- EMA Annex 11 computerised systems guidance and its document lifecycle expectations
- State-level retention divergence: California CMIA adds requirements beyond federal HIPAA floor
Recent material activity in Healthcare & Life Sciences
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CMS renews NCQA deeming authority for Medicare Advantage HMOs and PPOs for six years
On July 27, 2026, CMS approved NCQA's renewal application for Medicare Advantage deeming authority, covering Health Maintenance Organizations and Preferred Provider Organizations. The six-year term allows NCQA-accredited…
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ECDC publishes week 30 Communicable Disease Threats Report covering Ebola, West Nile Virus, and respiratory surveillance across EU/EEA
The European Centre for Disease Prevention and Control issued its weekly Communicable Disease Threats Report for the period 18 to 24 July 2026. The report covers active threat monitoring for Ebola, West Nile Virus, Crime…
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Baxter recalls single lot of Cefazolin in Dextrose Injection over cardboard particulate contamination
Baxter International announced a voluntary nationwide recall on July 24, 2026 of Lot LD175708 (expiry February 14, 2027) of Cefazolin in Dextrose Injection, USP, 2G/100mL, due to cardboard particulate matter found in sol…
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Baxter recalls single lot of Cefazolin in Dextrose Injection over cardboard particulate contamination
Baxter International announced a voluntary nationwide recall on July 24, 2026 of one lot of Cefazolin in Dextrose Injection, USP, 2G/100mL, due to cardboard particulate matter found in solution. The recall covers Lot LD1…
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FDA issues Early Alert on Boston Scientific ENROUTE carotid neuroprotection systems over arterial sheath tip separation risk
FDA's Center for Devices and Radiological Health issued an Early Alert on July 24, 2026 for specific lots of the ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus. Boston Sc…
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FDA issues Early Alert on Boston Scientific ENROUTE carotid neuroprotection systems over arterial sheath tip separation risk
FDA's Center for Devices and Radiological Health issued an Early Alert on July 24, 2026 for specific lots of the ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus. Boston Sc…
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FDA grants full approval to zidesamtinib for ROS1-positive NSCLC following prior TKI therapy
The FDA approved zidesamtinib (Jideytro, Nuvalent, Inc.) on July 22, 2026 for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who had received at least one prior ROS1 tyrosine kinase i…
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Sunny Pharmtech recalls three lots of injectable cyclophosphamide over steel particulate contamination
The FDA published a voluntary nationwide recall by Sunny Pharmtech, Inc. on July 24, 2026, covering three lots of Cyclophosphamide for Injection, USP, in 1g/vial and 2g/vial presentations. Steel particulate matter confir…
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FDA classifies diabetes digital behavioral therapeutic devices into Class II under special controls
On July 24, 2026, the FDA issued a final classification order placing diabetes digital behavioral therapeutic devices into Class II with special controls. The order establishes the regulatory pathway and codified special…
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FDA issues five-year import debarment order against Francis Esteban Matos following federal felony conviction
On July 24, 2026, FDA issued a final debarment order barring Francis Esteban Matos from importing or offering for import any drug into the United States for five years. The order follows a federal felony conviction for c…
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