The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more
NOTE FROM THE EDITORS -
The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more
8/13/2021
/ Artificial Intelligence ,
Clinical Trials ,
Connected Items ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Digital Health ,
Health Information Technologies ,
Infectious Diseases ,
Information Blocking Rules ,
International Tax Issues ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Medicare ,
Physician Fee Schedule ,
Popular ,
Public Health Emergency ,
Telehealth ,
Vaccinations
Note from the Editors -
Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more
1/29/2021
/ Artificial Intelligence ,
Asia Pacific ,
CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emergency Use Authorization (EUA) ,
European Commission ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
HIPAA Privacy Rule ,
Machine Learning ,
Popular ,
Telehealth ,
Telemedicine
Note From the Editors -
With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
7/21/2020
/ Acquisitions ,
Buyouts ,
CARES Act ,
Coronavirus/COVID-19 ,
Digital Health ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Foreign Direct Investment ,
Global Dealmaking ,
Investors ,
Life Sciences ,
Market Participants ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Popular ,
Private Equity ,
Public Health Emergency ,
Regulatory Requirements ,
Startups ,
Telehealth ,
Telemedicine ,
Venture Capital
The Situation: States have historically required close physician supervision of physician assistants, including, among other things, onerous chart review requirements, co-location of physicians on-site where physician...more
NOTE FROM THE EDITORS -
Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital...more
1/17/2020
/ 21st Century Cures Act ,
Clinical Trials ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Value-Added Tax (VAT)
The Situation: Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes.
The Issue: The health care industry, including the provision of health...more
2/1/2018
/ Artificial Intelligence ,
Corporate Practice of Medicine ,
Cybersecurity ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Malpractice ,
Medical Records ,
Personal Data ,
Popular ,
Regulatory Requirements
The Texas legislature passed S.B. 1107 yesterday, May 18, 2017.
The bill, negotiated with input from the Texas e-Health Alliance and various other stakeholder groups, expands options for health care providers utilizing...more