On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance"). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA's expectations for the use of Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...
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Recent Updates
- 2024 Update: Regulators Use “Carrots and Sticks” to Incentivize Healthcare Sector Cybersecurity Compliance
- Proposed Minnesota House Bill HF 4206 Would Prohibit Ownership Interests, Operational/Financial Control of Health Care Providers by Private Equity and REITS
- Proposed CA Assembly Bill 3129: Notice & Consent for Private Equity, Hedge Funds Acquiring/Changing Control of Health Care Facilities, Provider Groups
- Update: Alabama Legislature Moves to Shield IVF from “Personhood” Ruling
- Time Runs Out in the Oregon State Senate for HB 4130, but Will Likely Return in 2025