🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses
The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).
Learn More🔐Proposed HIPAA Security Rule Enhancements for Cybersecurity Compliance
The Department of Health and Human Services (HHS or "Department") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information ("Security Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, "regulated entities"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.
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