The Food and Drug Administration this week issued guidance intended to clarify the agency’s expectations when electronic health records are used as a source of data in clinical investigations. The guidance applies to clinical investigations of human drugs and biological products, medical devices and combination products, including investigations conducted in clinical practice settings.

Related News Articles

Headline
The Department of Health and Human Services today finalized its strategy to reduce regulatory and administrative burdens for health care providers using…
Headline
Less than 1% of the net electronic health record incentive payments Medicare paid to acute-care hospitals between Jan. 1, 2013 and Sept. 30, 2017 did not meet…
Headline
Critical access hospitals that did not achieve meaningful use of certified electronic health record technology in the Medicare Promoting Interoperability…
Headline
The Centers for Medicare & Medicaid Services today requested new and innovative ideas for reducing administrative burdens for health care providers and…
Headline
The AHA today shared with the Centers for Medicare & Medicaid Services a number of actions that the agency could take as part of its calendar year 2020…
Headline
Eligible hospitals and critical access hospitals that did not qualify as meaningful users of certified electronic health record technology for the 2019…