Tag Archives: Mobile medical apps

FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

In a new post on the Covington Digital Health blog, we analyze FDA’s proposed approach for device sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device.  FDA will hold a public hearing on November 16, 2017 to discuss DRDs.   To read … Continue Reading

FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] … Continue Reading

FDA Announces a New Digital Health Innovation Plan

FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … 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

France Boosts Its eHealth Initiatives

The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health.  The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity … Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical … Continue Reading

FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

FDA Finalizes Guidance Limiting Oversight of Certain Software Devices

On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices.  FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July … Continue Reading

21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software … Continue Reading

UK Data Protection Regulator Surveys Use of Smart Medical Devices

The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for medical device procurement policies, information governance and incident response … Continue Reading

Steps toward More Harmonized Regulation of Software as a Medical Device: New IMDRF Policy Position

On September 18, 2014, the International Medical Device Regulators Forum (IMDRF) approved a potentially significant policy position regarding Software as a Medical Device (SaMD), entitled Software as a Medical Device:  Possible Framework for Risk Categorization and Corresponding Considerations (IMDRF/SaMD WG/N12FINAL:2014).  The policy was put together by the IMDRF’s SaMD working group, led by an FDA … Continue Reading

FDA Launches OpenFDA To Ease Access to FDA Datasets — Which Creates Opportunities for Developers of Mobile Medical Apps

Last week, FDA launched openFDA­—its new, open government initiative.  Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets.  FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and … Continue Reading

Key Open Questions for FDA’s Upcoming Report on Regulation of Health IT

We’ve previously blogged about the “FDASIA Workgroup” and section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which directed FDA to issue a report to Congress by January of 2014 on the regulation of health technology.  This post covers some of the differing views on Health IT regulatory issues and open … Continue Reading

House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices

On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives.  The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.… Continue Reading

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of the … Continue Reading

FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year. Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for … Continue Reading

Coalition Seeks to Delay Mobile Medical Apps Guidance

This July will mark the two-year anniversary of FDA releasing its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  Finalizing the guidance document is listed as an “A list” item on the Center for Devices and Radiological Health’s proposed guidance development for Fiscal Year 2013, and … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

FDA Takes First Public Mobile App Enforcement Action

FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading
LexBlog