Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more
6/29/2020
/ Clinical Trials ,
Data Privacy ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
New Regulations ,
Pharmaceutical Industry ,
Privacy Laws ,
State Regulators ,
Technology ,
Telemedicine
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
6/2/2020
/ Biometric Information ,
Clinical Trials ,
Consent ,
Data Collection ,
Data Integrity ,
Data Privacy ,
Data Security ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Research and Development
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more