On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more
1/20/2020
/ 21st Century Cures Act ,
Artificial Intelligence ,
Big Data ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Machine Learning ,
Medical Devices ,
OMB ,
Policy Memorandums ,
Regulatory Agenda ,
Technology ,
Telehealth
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more
1/16/2020
/ 21st Century Cures Act ,
Artificial Intelligence ,
Big Data ,
Data Privacy ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Medical Devices ,
OMB ,
Policy Memorandums ,
Public Agencies ,
Public Interest ,
Regulatory Agencies ,
Regulatory Agenda ,
Risk Assessment ,
Risk Management ,
Technology ,
Telehealth ,
White Papers
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
2/7/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Devices ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more