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
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
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: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while also reducing the costs of care.
The Action: The Office of Inspector...more
11/25/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
ESRD ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Medicare Part B ,
OIG ,
Public Comment ,
Stark Law ,
Telehealth ,
Telemedicine ,
Value-Based Care
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
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more
8/19/2019
/ Artificial Intelligence ,
CLS Bank v Alice Corp ,
Digital Health ,
Healthcare ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
Technology ,
USPTO
The Situation: Recognizing the vital role that artificial intelligence ("AI") plays in the economy and national security interests of the United States, President Trump recently issued an Executive Order unveiling the...more
The Situation: Earlier this year, Congress passed the Bipartisan Budget Act of 2018 ("BBA"), which expands coverage for telehealth in Medicare Advantage ("MA") plans beginning in 2020.
The Update: The Centers for Medicare...more
On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...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: 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 Medical Board ("TMB") recently released proposed rules to implement Senate Bill 1107, which became law in May 2017 and allows for physician-patient relationships to be created solely through the provision of...more
In July 2017, the United States Department of Health and Human Services' Office of Inspector General ("OIG") revealed two new Work Plan items related to digital health: first, a review of Medicare incentive payments for...more
Although enacted more than 30 years ago, the Emergency Medical Treatment and Labor Act ("EMTALA") remains aggressively enforced and important for Medicare-participating hospitals to consider as they implement telemedicine...more
The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more
6/16/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
Health Care Providers ,
HITECH Act ,
Meaningful Use ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
OIG ,
Risk Mitigation ,
Settlement Agreements ,
Software ,
Third-Party Service Provider
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
A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more