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
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
This is the sixth 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 are the limits on how the data can be used and disclosed?… Continue Reading
This is the fifth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will pay for the offering?… Continue Reading
This is the fourth 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 data will be needed to substantiate the offering?… Continue Reading
This is the third of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the data used in the offering?… Continue Reading
This is the second of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the various components of the offering?… Continue Reading
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
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
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
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
On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading
On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension to the comment period for two rules proposed by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), originally published on March 4, 2019. These rules, discussed … Continue Reading
On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data. The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation … Continue Reading
Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here). The Updated Standards were produced following feedback … Continue Reading
On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), are intended to increase interoperability … Continue Reading
On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. The Taskforce has sought to clarify … Continue Reading
As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR. Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, available here.… Continue Reading
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
On 6 December 2018, the European Economic and Social Committee (EESC) published an opinion (“Opinion”) addressing the European Commission’s recent Communication on the digital transformation of health and care in the Digital Single Market (issued 25 April 2018). The EESC is an advisory body of the European Union (“EU”) comprising representatives of workers’ and employers’ … Continue Reading
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here. It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London. The Standards cover DHTs, such as apps, programs and software … Continue Reading
On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use technology across the health and care system, from “getting the … Continue Reading
On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study … Continue Reading
