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
The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more
The Situation: As the outbreak of the novel coronavirus disease (COVID-19) continues, telemedicine platforms are ideally situated to coordinate care and minimize exposure, while advancing access to care.
The Action:...more
Jones Day partners Alexis Gilroy and Maureen Bennett talk about lessons already learned from COVID-19, the questions clients are asking, why it's important that the world's health care organizations share information, and how...more
On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain.
The...more