Archives: Digital Health

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FTC to Consider Changes to the Health Breach Notification Rule

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and … Continue Reading

Recent Developments in Artificial Intelligence Law and Policy

Lee Tiedrich, B.J. Altvater, and James Yoon recently published an article summarizing recent developments in artificial intelligence law and policy on the University of Pennsylvania Law School’s Regulatory Review.  The article primarily focuses on developments in the United States, including the National Artificial Intelligence Initiative Act introduced by members of the House Committee on Science, Space, and Technology on March … Continue Reading

FDA Issues COVID-19 Policy for Certain Digital Health Solutions

On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written … Continue Reading

State Medical Licensing Changes to Combat COVID-19

The rapid spread of COVID-19 has transitioned the telehealth debate from a matter of access, convenience, and cost-saving to a matter of absolute necessity on a large scale. A variety of barriers have traditionally stood in the way of broader adoption of telehealth including a lack of reimbursement by both state and private insurance, restrictions … Continue Reading

AI Update: FTC Provides Guidance on Use of AI and Algorithms

On April 8, 2020, the Federal Trade Commission (“FTC”) released a blog post about the use of artificial intelligence (“AI”) and algorithms in automated decisionmaking. The blog highlighted the potentially great benefits and risks presented by increasingly sophisticated technologies, particularly in the “Health AI” space. However, it also emphasized that automated decisionmaking is not a new phenomenon—and … Continue Reading

The Potential Benefits of Digital Health Technology in Managing COVID-19

The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control … Continue Reading

Digital Health Alert: Product Liability Considerations for COVID-19-Related Solutions

Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19.  Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may reduce litigation risk down the … Continue Reading

Covington Publishes Coronavirus/COVID-19 Checklist for Technology Solutions

To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind (available here). For additional guidance, please visit our COVID-19 Legal and Business Toolkit (available here).… Continue Reading

European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad … Continue Reading

NHSX Consults on Draft Digital Health Technology Standard

On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here). The Standard, which is based on existing industry and health … Continue Reading

European Commission’s plans on data and Europe’s digital future (Part 3 of 4)

On 19 February 2020, the new European Commission published two Communications relating to its five-year digital strategy: one on shaping Europe’s digital future, and one on its European strategy for data (the Commission also published a white paper proposing its strategy on AI; see our previous blogs here and here).  In both Communications, the Commission … Continue Reading

EHR Vendor Admits to Soliciting and Receiving Kickbacks in Exchange for Promoting Prescription Opioids

Practice Fusion, Inc. (Practice Fusion), an electronic health record (EHR) vendor acquired by Allscripts in 2018, recently agreed to pay $145 million to resolve criminal and civil investigations related to an illegal kickback arrangement with a major opioid company. The settlement included $26 million in criminal fines and forfeiture to resolve two felony charges related … Continue Reading

New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy

The Institute of Global Health Innovation at Imperial College London has published a report called “NHS data: Maximising its impact on the health and wealth of the United Kingdom” (the “Report”).[1] The Report begins from the premise that the knowledge gleaned from the combination of patient health data and “big data” technologies has incredible potential … Continue Reading

Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government published a draft regulation setting … Continue Reading

European Parliament Endorses Digital Health Resolution

On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using … Continue Reading

Digital Healthcare Act Takes Effect in Germany

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 #8: What is Novel in the Digital Health Solution and What Will Give the Solution a Competitive Advantage?

This is the eighth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: what is novel in the digital health solution and what will give the solution a competitive advantage?… Continue Reading

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

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

EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these … Continue Reading
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