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Telemedicine and the Coronavirus Crisis: Key Legal Issues for Providers to Consider

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

States Relax Physician Assistant Supervision and Delegation Laws

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 TALKS®: COVID-19: Key Considerations for Health Providers & Life Science Companies [Audio]

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

Vital Signs: Digital Health Law Update | Winter 2020

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

OIG Proposes New Exception for Dialysis-Related Telehealth Technologies

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

OIG Approves Online Directory’s Per-Click Fees, Signaling Growing Acceptance of Healthcare Technology

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

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

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

White House Unveils American AI Initiative: The Future Is Now

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

CMS Proposed Rule Would Expand Coverage of Telehealth Benefits Under Medicare Advantage

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

FDA Releases Software Precertification Working Model

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

FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device

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

Artificial Intelligence and Health Care—Key Regulatory Considerations for U.S. Operations

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

Texas Medical Board Releases Proposed Rules to Implement New Telemedicine Law

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

Telehealth & EHR Meaningful Use Payments—Expect Greater Scrutiny in Upcoming Medicare Audits

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

Telemedicine in the Emergency Department and EMTALA Compliance

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

Texas Legislature Approves Bill Reducing Barriers for Telemedicine

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

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

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

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