The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
7/22/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Digital Health ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Personal Data ,
Pharmacies ,
Popular ,
Telemedicine
Holtec Palisades is the first project to receive a conditional funding commitment from the U.S. government through the Inflation Reduction Act's Energy Infrastructure Reinvestment ("EIR") program....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
3/20/2024
/ Consent ,
Data Privacy ,
Data Security ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
OCR ,
Personal Information ,
Popular ,
Risk Management ,
Telehealth
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
11/27/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Privacy ,
Data Security ,
DEA ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Popular ,
Public Health ,
Telehealth
The Michigan Senate recently passed a bill to repeal a long-standing state law immunizing pharmaceutical manufacturers and sellers from product liability suits where the pharmaceutical products were approved by the U.S. Food...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
9/25/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Supply Chain ,
Tracking Systems
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more
9/15/2023
/ Artificial Intelligence ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
End-Users ,
EULA ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
OIG ,
Popular ,
Software ,
Telehealth
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
Lawyer Spotlight:
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health. This month, we highlight two lawyers who help clients...more
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
3/9/2022
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Digital Health ,
Enforcement Actions ,
Federal Taxes ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
HIPAA Breach Notification Rule ,
Income Taxes ,
Life Sciences ,
Pharmaceutical Patents ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
State Taxes ,
Telecommuting ,
Telehealth ,
Telemedicine ,
USPTO
In support of the American Telemedicine Association's Telehealth Awareness Week (September 19-25, 2021), Jones Day's Digital Health team shared key insights on various legal topics applicable to telehealth. Jones Day's...more
9/27/2021
/ Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medical Reimbursement ,
Patient Access ,
Patient Privacy Rights ,
Rate Parity Agreement ,
Relief Measures ,
Rural Health Care Program ,
Taxable Income ,
Telehealth ,
Telemedicine
The COVID-19 pandemic has raised concern among health care leaders about the preparedness of acute care systems to adapt to and manage large-scale environmental disruptions. Current physician compensation models do not align...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
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
The Situation: The Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") released an advisory opinion providing new insight into the evaluation of fraud and abuse risks of per-click fee...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more
With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more
3/25/2019
/ ACOs ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Exceptions ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U.S. Food and Drug Administration. They discuss how the FDA is addressing the...more
The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more
11/8/2018
/ Administrative Procedure Act ,
Affordable Care Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Final Rules ,
Medicare Advantage ,
Overpayment ,
Overpayment Recovery Time Limits ,
Social Security Act ,
Vacated
Jones Day’s Ann Hollenbeck and Courtney Carrell discuss an unexpected False Claims Act action as a private equity firm faces FCA liability. They also discuss the implications to consider when Uber, Lyft, and other rideshare...more