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Healthtech

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Patient registries are where big data meets new and exciting regulatory opportunities in pharma, and regulators are keen to address the gaps between regulation and innovation in this space. The European Medicines Agency (EMA) has published new draft guidelines on registry-based studies (Guidelines) for a three-month public consultation period. The Guidelines make the case for optimising the use of registry-based studies as a source of real-world evidence. The new Guidelines will be an essential tool…

What are the legal challenges of bringing such innovative and scalable products to the market?  In this webinar, we will explore a case study on a drug-device combination product with a strong digital component. These types of products are becoming increasingly sophisticated and they raise new opportunities, but also new challenges from a legal point of view. We will discuss the legal challenges for a company bringing a digital health product to market with a specific focus…

The challenge Digital technologies have become integral to all sectors, and none more so than the healthcare industry. Companies in the healthcare industry are investing significantly in the conception, development, manufacturing, sale and distribution of “HealthTech”. It is important to protect and ensure a return on this investment through a strategic use of the available IP and trade secrets laws. In particular, it is important to take a holistic approach to the use of IP…

New guidelines have been published on clinical trials for AI health solutions. The SPIRIT-AI extension relates to clinical trials protocols, and the CONSORT-AI extension is a new reporting guideline for clinical trial reports. These new guidelines are aimed at addressing some of the chronic issues which often underlie trial standards for AI, including the use of retrospective datasets, poor standards of reporting and lack of transparency. We’ve described these issues below: 1. Retrospective reports do…

The UK’s National Data Guardian for Health and Social Care (NDG) is carrying out a consultation seeking views on proposed revisions to the seven Caldicott Principles. The consultation is open until 3rd September. We’ve set out a summary of 4 key changes proposed in the NDG’s consultation paper. What are the Caldicott Principles? In 1997, Dame Fiona Caldicott chaired a committee which produced a report containing six principles on patient confidentiality after reviewing the transfer…

For some time now, start-ups, health care and tech companies have been experimenting with smaller video games to have people around the world help with categorizing or analyzing big data sets that typically take months or even years to analyze. The idea is that if everybody invests only a few minutes, the work could be done in days or weeks instead of years. A player who participates has to solve a few simple matchmaking or…

The Digital-Supply-Act (Digitale-Versorgung-Gesetz, “DVG”), which aims to further promote digitization in the German health care system, entered into force on 19 December 2019 and regulates, inter alia, the prescription of Digital Health Apps by HCPs (including the cost bearing by statutory health insurance). Patients insured with statutory health funds are eligible for reimbursement of Digital Health Apps. As of this August, prescription for Digital Health Apps will be available, according to statements made by the…

Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…

Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…