UK Law and Practice Contributed by: Amélie Chollet, Hannah Curtis and David Dennis, CMS
Further guidance regarding directly bookable appointments was introduced in October 2022. This sets out requirements for online appoint- ment booking following changes to General Med- ical Services (GMS), Personal Medical Services (PMS) and Alternative Provider Medical Services (APMS) contractual arrangements that came into effect in England from October 2022. Practices must now ensure that all of their “directly book- able” appointments are made available online, as well as by phone or in person. GMC professional standards apply regardless of whether the digital health service is provided by UK-based or foreign practitioners. Any doctor providing services to UK patients must comply with them. 2.3 Role of Policymakers Policymakers play a key role in the regulation and oversight of digital healthcare in the UK, including in the following ways. Updating Regulations The government, and MHRA in particular, regu- larly review and update medical device regula- tions to keep pace with technological advanc- es. For example, the new GB Medical Devices Regulations will introduce changes specific to software as a medical device (SaMD), including definitions, classification rules and cybersecurity requirements. Consultation and Guidance The MHRA also consults with stakeholders and issues guidance on new technologies when these emerge. For example, between September and November 2021, the MHRA consulted on proposed changes to the regulatory framework for medical devices in GB. The government then published a response to the 2021 consultation, which outlined proposed changes to address
emerging technologies and next steps for the MHRA in order to implement a transformed reg- ulatory framework. Oversight and Enforcement The MHRA is the regulatory agency with statu- tory powers to regulate medical devices, includ- ing SaMDs, and to enforce applicable legislation. Applicable guidance, while not legally binding, is authoritative in how the applicable require- ments should be interpreted. Other regulatory bodies such as the CQC, GMC and Information Commissioner’s Office (ICO) oversee compli- ance and enforce standards. The CQC regu- lates telehealth/telemedicine service providers in England, the GMC regulates individual medical practitioners in the UK, and the ICO enforces The launch of the Office for Digital Health includes a key strategic aim to improve digital health approval pathways and reimbursement policy relating to telemedicine and healthcare mobile apps. Policymakers are also involved in developing standards and guidance for the use of telemedicine and digital health tools. International Alignment data protection laws. Strategic Initiatives The UK continues to monitor and, where appro- priate, align with international standards and definitions, such as those developed by the European Commission and the International Medical Devices Regulators Forum (IMDRF). 2.4 Technical Standards GB Essential requirements Under the Medical Devices Regulations 2002 (as amended), medical device software must meet essential requirements for safety and per- formance. These cover software life cycle pro-
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