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FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

Earlier today, on the InsideMedicalDevices blog, our colleague Christopher Hanson posted a summary of the FDA’s recent issuance of draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by the FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”  You … Continue Reading

New CMS Rule Permits Home Health Face-to-Face Encounters to Occur Through Telehealth Technology

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) finalized a rule implementing a provision of the Affordable Care Act (ACA) that requires a Medicaid enrollee seeking coverage for home health services to first meet face-to-face with a practitioner.  The final rule confirms that the face-to-face encounter requirement “may occur through telehealth, as implemented … Continue Reading

Health Care Providers Continue to Lag Behind Patient Demand for Digital Communications

While Americans continue the trend towards replacing the traditional phone call with email and texts, health care providers have yet to catch on when interacting with their patients. A recent survey by Nielsen Strategic Health Perspectives found that less than a third of Americans have access to digital communications with their physicians: The survey found … Continue Reading

FDA Regulatory Science Priorities Address Use of Data, Health Information Technology

On October 20, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its top ten Regulatory Science Priorities for FY 2016 to facilitate improvements in the safety and effectiveness of medical devices and accelerate innovation. Several of the priorities would harness health information technology or health data to … Continue Reading

HHS Launches Portal Seeking Questions from Mobile Health Application Developers

A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers.  The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications.  To read the post, click here.… Continue Reading

Multistakeholder Group Seeks Comment on Draft Framework for IoT Device Manufactures

Last week, our colleague Libbie Cantor published a post on our InsidePrivacy blog regarding the Online Trust Alliance’s (OTA) release of a draft framework of best practices for Internet of Things device manufacturers and developers.  This draft framework applies to, among other things, eHealth technology, such as wearable fitness and health technologies.  The OTA is seeking comments on … Continue Reading

Cybersecurity Risks with Connected Devices

Earlier this week, our colleague Bianca Nunes published a post on cybersecurity risks with connected devices on Covington’s InsideMedicalDevices blog.  This post describes the FDA’s increasing focus on promoting cybersecurity, as well as a draft practice guide for securing health records maintained on mobile devices published by the National Institute of Standards and Technology (NIST).… Continue Reading

Comments Requested on Draft Guide on Securing Electronic Health Records on Mobile Devices

The National Cybersecurity Center of Excellence (“NCCoE”) has released a draft for public comment of the first guide in a new series of publications “that will show businesses and other organizations how to improve their cybersecurity using standards-based, commercially available or open-source tools.” The guide discusses how to secure electronic health records on mobile devices. … Continue Reading

Nine States Join Interstate Medical Licensure Compact

* Alex Langton is a summer associate and student at Georgetown University Law Center. In May, three states joined the Interstate Medical Licensure Compact, in addition to the six states that had already joined.  A sufficient number of states have now joined to trigger implementation of the Compact through the creation of the “Interstate Medical Licensure … Continue Reading

21st Century Cures Act with EHR and Telehealth Provisions Passes Through Committee with Flying Colors

* Jack Lund is a summer associate and student at the University of Virginia School of Law        The “21st Century Cures Act” (Cures) cleared its first major hurdle last month when the House Energy and Commerce Committee voted unanimously in favor of the legislation.  Among other things, Cures helps to modernize Medicare by … Continue Reading

May 2015 EU mHealth Round-Up

May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention.  The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just weeks earlier.  In parallel, the French data protection authority announced … Continue Reading

Several States Enact Telehealth Parity Laws in 2015

* Gabriel Kohan is a summer associate and student at Harvard Law School.         States are continuing to debate the role telehealth services should play in the health care system. Thus far in 2015, several States have enacted parity laws requiring that certain telehealth services be reimbursed to the same extent as in-person services. While on … Continue Reading

FDA Regulation of mHealth Updates

At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.”  As we discussed in a previous post (see here), there have already been several … Continue Reading

The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies

Earlier this month, the National Law Journal published its annual Special Report on Health Care Law. Included in this Special Report is an article written by CovingtonEHealth contributors Caroline Brown, Anna Kraus, and Phil Peisch, entitled, The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies. This article explores how … Continue Reading

EU Advisory Board Clarifies Scope of Health Data in Apps and Devices

Our colleague Monika Kuschewsky recently published a post on the InsidePrivacy blog describing how the Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s mHealth initiative to clarify the definition of data … Continue Reading

Michigan Launches First Medicaid Mobile Application

The Michigan Department of Community Health (MDCH) recently released the nation’s first Medicaid mobile health application, called myHealthButton, and an online portal, myHealthPortal, that allows patients to access their medical information and available health resources remotely and in real-time.  The applications are available to current members enrolled with the Michigan Medicaid program, the Children’s Special … Continue Reading

Upcoming Webinar: Regulation of eHealth Products and Mobile Apps (February 25, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST). Our panelists, including two alumni of the FDA Office of Chief Counsel, will address: What factors determine whether an eHealth product is considered a medical device … Continue Reading
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