Archives: Medical Apps

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Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health Solutions 1. What are … Continue Reading

AG Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices. … Continue Reading

FDA Initiates Software Precertification Pilot Program

On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice.  The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan.  CDRH also held a webinar on August 1 to provide an overview of the program and answer … Continue Reading

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading

ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an … Continue Reading

HHS Issues Guidance on HIPAA and Cloud Providers

The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs). In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business … Continue Reading

New EU Medical Device Guidance on Standalone Software

On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012. MEDDEV 2.1/6 generally stands as a … Continue Reading

ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media

Earlier this month the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), released a report to Congress highlighting “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by certain “mHealth technologies” and “health social media.” mHealth technologies … Continue Reading

Significant HIPAA Fine Follows Business Associate’s Stolen iPhone

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently announced a significant settlement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a business associate under HIPAA, arising from a breach of protected health information (PHI) after the theft of an employee’s iPhone.  The iPhone … Continue Reading

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
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