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K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers - Part III: FDCA

K&L Gates LLP on

This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more

Perkins Coie

DHHS Updates Resources for Mobile Health App Developers

Perkins Coie on

The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps)....more

Polsinelli

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

Polsinelli on

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

Mintz - Health Care Viewpoints

AMA Ethical Guidelines on Telemedicine Tabled for Further Review

Mintz - Health Care Viewpoints on

On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services....more

Mintz - Health Care Viewpoints

Injunction Blocks Implementation of Texas Telemedicine Regulations

Mintz - Health Care Viewpoints on

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that...more

Knobbe Martens

PilotFish Announces MedDevice Connection App

Knobbe Martens on

Applied PilotFish Healthcare Integration, Inc. (APHII) recently announced a new application called HealthConnect. APHII is the healthcare division of PilotFish Technology, a provider of middleware solutions for the...more

Dickinson Wright

Healthcare Legal News Volume 5 Number 2

Dickinson Wright on

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Mintz - Health Care Viewpoints

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Mintz - Health Care Viewpoints on

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

Mintz - ML Strategies

Telehealth, Health IT, and mHealth Policy: Considerations for Stakeholders

Mintz - ML Strategies on

In recent months, as the conversation about reforming the health care system has shifted from websites and coverage expansion to achieving greater delivery system efficiencies, cost containment, and quality improvement, the...more

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