Telemedicine

News & Analysis as of

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Draft Guidelines for TeleICU Operations Released

The American Telemedicine Association released draft Guidelines for TeleICU Operations on March 28, 2014 and is seeking public comments through April 26, 2014. Practice guidelines can serve as a useful reference point...more

Mobile Medical App Regulations on the Move – Proposed Bills To Further Alter the Regulatory Landscape of Mobile Medical...

Apple’s apps store lists close to a 100,000 health apps. Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare...more

Interstate Medical Licensing Compact Could Pave a Smoother Path for Telemedicine Providers

One of the largest hurdles to the growth of telemedicine – streamlined physician licensure in multiple states – soon may be addressed. The Federation of State Medical Boards (FSMB) will vote on adopting the federation’s...more

Florida Department Of Health Adopts New Telemedicine Rule: Florida Legislature Considers Changing The Law

While the Florida Department of Health (DOH) adopted a new telemedicine rule on March 12, 2014 [Rule 64B8-9.0141 and Rule 64B15-14.0081 of the Florida Administrative Code], several bills on the same subject are under...more

Health Care E-Note - March 26, 2014

In This Issue: - Hospital CEO Turnover Rate Reached Record 20 Percent in 2013 - States Take on Authority of Doctors vs. Advanced Practice Nurses - HHS Urges Hospitals to be More Prepared for Emergencies -...more

Federation of State Medical Boards to Vote on Telemedicine Policy

The March 20th edition of Modern Healthcare reports on a “patient centered telemedicine policy” to be voted on by the Federation of State Medical Boards (FSMB). I’ve attached links to both the article and to the FSMB model...more

Your smartphone is NOT a medical device

Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more

Telemedicine Expansion—Navigating Potential Pitfalls

The fervent debate on health care underscores the need to deliver and make accessible quality health care to patients throughout the United States in an efficient and cost-effective manner. Amidst technological advancements,...more

Telemedicine: More Than New Technology

Technological advancements and the expansion of access to health care under the Affordable Care Act have pushed telemedicine to the new frontier of health care delivery. Originally Published in For The Record -...more

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

Medicare Physician Fee Schedule Expands Telehealth Coverage in 2014

The Centers for Medicare & Medicaid Services (“CMS”) recently released the final rule for Medicare’s Physician Fee Schedule for 2014 Calendar Year (“CY). While physicians are expected to see a 20.1% reduction to their...more

CMS Releases Final Rule for 2014 Medicare Physician Fee Schedule

CMS has released its much-anticipated final rule with comment for the Calendar Year (CY) 2014 Medicare Physician Fee Schedule (PFS). The final rule prescribes physician payment rates that will go into effect on January 1,...more

Congress Wades in to Medical App Oversight

In September 2013, the Food and Drug Administration (FDA) issued final guidance regarding its regulation of mobile device medical apps. As expected, it reserved its scrutiny for apps that are truly “medical devices” (because...more

FDA Finalizes Guidance on "Mobile Medical Applications"

On September 25, 2013, the Food and Drug Administration (FDA) issued final guidance on Mobile Medical Applications – healthcare related software applications intended for use on mobile platforms such as smartphones and...more

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

FDA Issues Final Guidance on Mobile Medical Apps: “De-Regulatory” Move Helps Clarify Certain Key Questions, But Leaves Others Open

On September 25, 2013, the Food and Drug Administration (FDA) issued its long-awaited final guidance on health-related software applications intended for use on mobile devices. Under the guidance, FDA will regulate only those...more

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more

FDA Issues Final Mobile Medical App Guidance

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more

CMS Proposes Policy and Payment Changes for the CY 2014 Medicare Physician Fee Schedule

On July 8, 2013, CMS issued a proposed rule setting forth a range of program changes and initiatives relating to the Medicare Physician Fee Schedule (PFS) for Calendar Year (CY) 2014. Most notably, the proposed rule announces...more

FDA Flexes Mobile App Enforcement Muscles (Gently)

The FDA was granted authority to regulate mobile health care applications (apps) as part of the Food and Drug Administration and Innovation Act. (For a detailed discussion of the FDA’s authority, see “FDA Safety and...more

FDA Letter to Mobile App Developer Signals Regulatory Scheme

Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more

FDA Scrutinizes Mobile Medical App – Intriguing Letter to App Developer Precedes Expected Release of Final Guidance

On May 21, 2013, the Food and Drug Administration (“FDA”) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited, the developer of the uChek Urine Analyzer app. The app, available since April...more

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