Archives: Health Data

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HHS Seeks to Facilitate Certain Uses and Disclosures of Health Data to Public Health and Health Oversight Agencies Amidst COVID-19 Nationwide Public Health Emergency

On April 2, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding the disclosure of protected health information (“PHI”) to public health authorities and use of PHI to perform analytics for such authorities.  Designed to “facilitate uses and disclosures for public health and health oversight … 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

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

HHS Finalizes Interoperability Rules

On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI.  The rules, which were issued by the Office of the National Coordinator for Health Information Technology (ONC) and … Continue Reading

Procurement Tenders in the Health Sector: More Protection for Patient Data

On March 6, 2020, the Italian Data Protection Authority (“Garante”) reported on new measures designed to protect the health data of patients in the context of Government procurement efforts (calls for tender) to acquire medical equipment and devices. The new measures are the result of a collaboration between the Garante and Consip, a company wholly … 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 Presents Strategies for Data and AI (Part 1 of 4)

On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this … 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

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

Top 10 Questions During Ideation of Digital Health Solutions

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

Commission relaunch of eHealth Stakeholder Group

On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and 2015), contributed to the development … Continue Reading

German Government Enacts Digital Care Act

The new Digital Care Act (Digitale-Versorgung-Gesetz) is part of Germany’s efforts to expand the digitization of the healthcare system in Germany. Germany has already been pursuing this path since the so-called ‘E Health Act’ from 2016. The aim of the ‘E-Health Act’ was to establish information and communication technology in healthcare. It focuses in particular … Continue Reading

FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence

Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading
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