Tag Archives: Medical Devices

Digital Healthcare Act Takes Effect in Germany

By Ulrike Elteste on Posted in Digital Health
Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the elements of the Digital Healthcare Act 2019 (Digitale Versorgung-Gesetz), which we discussed in an earlier post this year and which was approved by the German Parliament in November and published on … Continue Reading

Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

By Sarah Franklin on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA
This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?… Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Elizabeth Guo, Christina Kuhn, Wade Ackerman and Scott Danzis on Posted in Artificial Intelligence (AI), Digital Health, Medical Apps, Medical Devices and FDA, Software
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

Top 10 Questions During Ideation of Digital Health Solutions

By Christina Kuhn, Wade Ackerman and Sarah Cowlishaw on Posted in Data Security, Health Data, Medical Apps, Medical Devices and FDA
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions.  “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested.  Covington has created a Top 10 Questions for Ideation of Digital Health … Continue Reading

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

By Harriet Fletcher and Sarah Cowlishaw on Posted in Cybersecurity, European Union
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

By Elizabeth Guo, Scott Danzis, Wade Ackerman and Lindsey Tonsager on Posted in Artificial Intelligence (AI), Innovation, Medical Apps, Medical Devices and FDA, Software
On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading

Are Wearables Medical Devices Requiring a CE-Mark in the EU?

By Covington Digital Health Team on Posted in European Union, Health Data, Innovation, Internet of Things (IoT)
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases … Continue Reading

UK Government publishes “Initial code of conduct for data-driven health and care technology” for consultation

By Joshua Gray on Posted in Artificial Intelligence (AI), Big Data, EU Data Protection, Government Contracting, Health Data, HIPAA and Data Privacy, Medical Apps, Personalized Medicine, UK National Health Service
On 5 September, in response to the opportunities presented by data-driven innovations, apps, clinician decision support tools, electronic health care records and advances in technology such as artificial intelligence, the UK Government published a draft “Initial code of conduct for data-driven health and care technology” (Code) for consultation.  The Code is designed to be supplementary … Continue Reading

Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies

By Priscilla Fasoro and Covington Digital Health Team on Posted in Cybersecurity, Government Contracting, Internet of Things (IoT), Medical Apps, Medical Devices and FDA
Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. However, … Continue Reading

FDA Outlines Updated Approach to Regulating Digital Health Technologies

By Christina Kuhn, Wade Ackerman, Scott Danzis and Covington Digital Health Team on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the … Continue Reading

The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective

By Grant Castle, Sarah Cowlishaw, Scott Danzis and Christina Kuhn on Posted in Medical Devices and FDA
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as … Continue Reading

AG Opinion on Software Medical Devices

By Sarah Cowlishaw on Posted in Medical Apps, Medical Devices and FDA
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

By Christina Kuhn on Posted in Medical Apps, Medical Devices and FDA
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

OIG FY 2016 Work Plan Includes Review of FDA’s Oversight of Networked Devices

By Christina Kuhn on Posted in Cybersecurity, EHR/EMR, Medical Devices and FDA
On November 2, 2015, the HHS Office of Inspector General (OIG) published its FY 2016 Work Plan, which summarizes new and ongoing activities that OIG plans to pursue with respect to HHS programs and operations during the fiscal year. The FY 2016 Work Plan includes a new review initiative to examine “whether FDA’s oversight of … Continue Reading
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