In a survey involving nearly 2.000 decision makers working in the healthcare industry released in 2022 by Simmons & Simmons[1], it appears clearly that Covid 19 has been a game changer for the healthcare sector and has accelerated opportunities for technological disruption.
New treatments against rare and serious diseases, new vaccines, assistance to a more accurately and effectively diagnose, remote care of patients, health, technologies offer a wide range of amazing possibilities. 93% of respondents said that internal business changes will be necessary to unlock digital health opportunities in the next 12 months. These changes are traveling with a complexification of the legal framework that creates new challenges for the industry.
The very first on the list is how the use of technologies impacts medical liability? As the result of the growing use of devices and processes based on artificial intelligence, helping physicians to identify patterns and make diagnostics more efficient, the traditionally bilateral relationship between a practitioner and his patient is transformed into a more complex tri or multi dimensional question. New liability related questions arise necessarily: how can the practitioner be responsible for a medical decision based on data issued from an imperfect medical device? What about the responsibility of doctors relying through a telehealth platform on an app measuring the possible malignancy of a mole? Who’s fault is it if the diagnostic is wrong? There is a very thin line between the responsibility of the producer of a device and the one of the practitioner using it.
Between these 2, it is even possible that the patient plays an active role in the diagnostic by operating himself the device. And what about the owner of the telehealth platform or the smartphone manufacturer? All this is uncharted territory and opens the doors to endless multiple parties and complex litigations.
The issue is particularly critical when it comes to artificial intelligence (AI), as machine can not only be a tool used in a decision process but take its own “decisions”. This would be the case for instance when a medical device relying on artificial intelligence is used to monitor a chronic disease and gives medical instructions to the patient.
These examples illustrate the necessity of a clear legal framework to make the use of innovative products a safe and reliable process for all parties. This large-scale work has already been engaged notably through the adoption of the EU medical devices regulations (MDR and IVDR)[2] that set and unifies the regulation applicable to medical devices through the CE marking. MDR covers a wide range of products, but some still remain out of scope. This is particularly the case for many apps available on the market. With products on the hedge of MDR, the challenge is to identify those who offer sufficient reliability, and the question of a quality labelling could be an option. This is an additional challenge for the regulatory authorities.
Additionally, most of the liabilities issues will soon be tackled by the two directive proposals so called “Product Liability”[3] and “Artificial Intelligence”[4]. Other crucial issues such as cybersecurity, the protection of personal and sensitive data are also of particular relevance. The risk of being hacked is even more worrying when it comes to processing large amount of medical data. The risk is not only the continuation of the business but the very specific liability for those involved in the dissemination of sensitive data. This shows how complex the sector is, and how the regulation is essential.
Our survey however reveals that, on the other hand, from the industry perspective “legal aspects are among the diverse issues putting breaks on faster progress. Pressure is building in several emerging areas of law that [legal] counsel must start to deal now”. In this survey, industry also shared a general concern about an increase of dispute. Contractual disputes, product liability and intellectual property are among the top areas where industry fears an increase of dispute[5]. Perfectly drafted contracts are a must to mitigate some of these risks. This is particularly right for intellectual property issues.
We know from experience that a large part of digital health products are created through partnerships: a party having a scientific experience and a large production capacity may be tempted to collaborate with a start-up owning a breakthrough technology. These partnerships imply to assemble together a wide range of elements (such as data, knowledge, know-how, existing IP rights, confidential information). The contractual framework ruling these collaborations must be the way to mitigate the risks, particularly when most of the value created relies on IP rights.
[1] “Legal trends herald ear of opportunity, The future of healthcare and life sciences, Simmons+Simmons, (Foleon Preview).
[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC andRegulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
[3] Proposal for a Directive of the European Parliament and o the Council on liability for defective products, date of 28.09.2022
[4] Proposal for a Directive of the European Parliament and o the Council on adapting non-contractual civil liability rules to artificial intelligence, dated of 28.09.2022.
[5] “Legal trends herald ear of opportunity, The future of healthcare and life sciences, Simmons+Simmons, p. 20 (Foleon Preview).
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