Tag Archives: digital health

UK Government Announces Review Into Use Of Health Data For Research And Analysis

On February 9, 2021, the UK Government’s Department for Health and Social Care (“DHSC”) announced a review into the efficient and safe use of health data for research and analysis for the benefit of patients in the health sector (“Review”). The DHSC encourages stakeholder feedback in the context of the Review, and will be of … Continue Reading

FTC Reaches Settlement with Digital Health App, Requires First Notice of Privacy Action

The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information would be kept private.”  The proposed settlement … Continue Reading

UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies

On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”)  published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”).  The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here). As … Continue Reading

HHS Launches New “Health Apps” Website to Highlight HIPAA Guidance for Mobile Health Applications

On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website.  The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability Act (“HIPAA”) … Continue Reading

FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices

On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software. The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which added … Continue Reading

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

NHSX Publishes “Buyer’s Checklist” for AI Solutions

NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise).  For example, the Guidance highlights: key data-related considerations, such as can the outcome … 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

COVID-19: FDA Regulatory Considerations for Digital Health Solutions

Digital health companies are playing an important role in the global response to the COVID-19 public health emergency.  For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19.  As readers of this blog are aware, some … 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

European Commission’s White Paper on Artificial Intelligence (Part 2 of 4)

The European Commission, as part of the launch of its digital strategy for the next five years, published on 19 February 2020 a White Paper On Artificial Intelligence – A European approach to excellence and trust (the “White Paper”).  (See our previous blog here for a summary of all four of the main papers published … 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

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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