INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst
telehealth fraud and over-utilisation by practi- tioners following the expanded use of telemedi- cine services. Liability Digital healthcare poses several legal risks, including privacy and security challenges, inter- operability issues, and the increased involve- ment and reliance on third parties, which can lead to intended or unintended responsibility gaps. Legal issues also arise from the lack of comprehensive and harmonised pre-market regulatory frameworks, resulting in inconsistent enforcement and gaps in protection. The rapid pace of technological advancements often out- strips existing regulations, creating challenges in ensuring that new digital health solutions com- ply with current legal standards and adequately protect patient safety and privacy. Companies not specialised in healthcare but tapping into healthcare services/products may face signifi- cant regulatory challenges. Fragmented and inconsistent regulatory land- scapes, which complicate the enforcement of standards and protections across different juris- dictions, might be very unclear to, for example, manufacturers of digital healthcare applications. Additionally, the lack of specific regulations for emerging technologies, such as AI and machine learning in healthcare, further complicates enforcement efforts, as authorities struggle to apply existing frameworks to new and com- plex digital health solutions. If the digital health product leads to damage to consumers, typically the “enforcement” will be imposed by affected consumers’ or competitors’ claims via litigation. There is often great complexity in determining responsibility among multiple stakeholders, such as healthcare providers, technology devel- opers and manufacturers. This can complicate
contractual and statutory obligations and make determination of resultant liability more difficult. Liability frameworks for digital healthcare are generally based on general liability regimes, including contractual claims, tort, common law principles, and strict product liability. In the EU, the Product Liability Directive (PLD) harmo- nises liability across the member states and falls under the Representative Actions Directive (RAD) regime currently being brought into effect across the EU. This means that product liability claims can be brought on behalf of consumers in some form of class action system. Some of the jurisdictions (eg, Germany) enabled “class actions” aimed at redress for the first time, with the implementation of the RAD in October 2023. This might increase the exposure of manufac- tures of digital health products in the EU member states significantly, as the RAD further provides for the possibility of cross-border claims. To mitigate against legal exposures, companies can: • adhere to industry standards (where avail- able); • obtain necessary regulatory approvals; • document testing against standards; • enable proper quality surveillance systems; • implement robust compliance systems; and • include contractual safeguards such as indemnity clauses, warranties and clear allo- cation of responsibilities. Emerging Legal Issues and Reform Recent developments in digital healthcare tech- nology include a continued focus on: • AI and ML; • virtual and augmented reality; • automation of administrative processes;
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