UK Law and Practice Contributed by: Amélie Chollet, Hannah Curtis and David Dennis, CMS
Cost Impact Digital healthcare improves efficiency and resource allocation, reducing overall healthcare costs. The use of digital tools can reduce unnec- essary hospital visits and admissions by ena- bling remote monitoring and early intervention. Support for Healthcare Professionals Digital health apps, especially those used for clinical decision support, can assist doctors in making more accurate diagnoses and treat- ment decisions, improving patient safety and outcomes. Efficiency for Healthcare Professionals Digital records, automated reminders and clini- cal decision support streamline workflows and reduce administrative burdens. For example, electronic patient records facilitate the sharing of information among healthcare professionals, improving co-ordination and continuity of care. 2. Legal Framework 2.1 Definition of Digital Healthcare There is no single regulatory definition of “digital healthcare” in the UK. While the term is widely used in policy and guidance, associated legal obligations are generally triggered by the func- tion of a product (for example, whether it is a medical device or involves the processing of personal data). However, the term is generally understood as the use of technology (such as apps, programs, software, etc) in healthcare – either standalone or combined with other products such as therapeutics, diagnostics or medical devices. This can also be referred to as eHealth or digital health services. It is worth noting that currently two sets of regu- lations coexist in the UK, as a result of the North-
ern Ireland (NI) Protocol and Windsor Framework, which maintains alignment with certain EU rules in NI. Following Brexit, Great Britain (England, Wales and Scotland) (GB) is governed by the Medical Devices Regulations 2002 (MDR (GB)), while NI is governed by the EU Medical Device Regulation (2017/745) and the In Vitro Diagnos- tic Medical Device Regulation (2017/746). The UK and EU regulatory documents and guid- ance use terms such as “digital healthcare”, “eHealth” or “digital health services” in line with international understanding, and definitions are often informed by European Commission guid- ance and international standards (eg, MEDDEV 2.1/6 for software, which was superseded by the Medical Device Coordination Group (MDCG) Guidance 2019-11). MDCG 2019-11 retained the MEDDEV 2.1/6 guidance’s definition of “software” as “a set of instructions that processes input data and cre- ates output data” and further defined “input data” and “output data”. It introduced a new definition specifically for “medical device soft- ware” (MDSW): “medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a ‘medical device’ in the Medical Devices Regulation or In Vitro Diagnostic Medi- cal Devices Regulation.” The MDCG Guidance also provided guidance on the qualification and classification of software as a medical device. The Medicines and Healthcare products Regu- latory Agency (MHRA) has developed its own guidance framework, whose substance still broadly aligns with the EU approach. In prac- tice, however, with the MHRA’s signalled intent to focus on innovation-friendly approaches to
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