London Tech Week 2025 is here, a flagship event, where global visionaries, tech leaders, founders and top investors share their insights into the future of technology.
This year healthtech is in the spotlight again, which is unsurprising, given the accelerating impact of technology on healthcare provision, tackling long-standing problems and improving outcomes.
Technology is rapidly revolutionising healthcare. We can see this in expanded access to care through the use of remote consultations, wearable devices and apps; a reduction in healthcare costs through the management of electronic health records; the improvement in diagnostics through sophisticated AI-driven solutions; more personalised care; and the prevention of errors and prediction of outcomes through data management and analytics tools.
Legal and regulatory frameworks are also evolving to match technological progress. Currently, there are a number of key legal elements for a healthtech business to consider if operating in, or seeking to expand into, the UK.
Data protection and privacy
Any businesses with operations in the UK involving the collection and processing of personal data must ensure that it complies with the UK GDPR and the Data Protection Act 2018. The regime imposes a range of obligations on businesses dealing with personal data., This includes, among others, requirements to provide certain information to individuals; requirements relating to the export of personal data outside the UK, ensuring compliance by third party data processors; IT and physical information security; security breach notifications; and more.
Failure to comply with the UK data protection legislation may carry significant implications for a business, including multi-million administrative fines and far-reaching reputational damage.
Businesses must therefore carefully assess their data protection obligations and have in place robust policies and procedures, including cybersecurity measures, to ensure adequate compliance.
Regulation of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices, including digital health technologies. Detailed rules apply, based on the classification of devices into specific categories. Devices must also meet UKCA (UK Conformity Assessed) or CE (Conformité Européene) marking requirements.
NHS partnerships and procurements
The NHS is the largest customer of healthcare products and services in the UK. Companies aiming to partner with, or sell products or services to, the NHS will be required to navigate procurement rules, which may include public tenders and standardised terms and conditions of sale. Demonstrating clinical effectiveness and cost effectiveness, among others, will be key for market access.
Broader regulatory considerations
Businesses operating, manufacturing or conducting research must assess specific regulatory requirements applicable to them and adhere to relevant legislation.
Intellectual property
IP protection is key for any innovative or knowledge-rich business. Such businesses should consider registration of trade marks and patents where appropriate, as well as protecting their unregistered IP rights. The latter may involve adequate licensing arrangements, contractual provisions dealing with IP ownership (in particular, where IP is developed by, or with, others) and careful consideration as to the use of open source software. Carefully drafted commercial agreements with partners, suppliers, developers, customers, employees and consultants are key.
Liability and risk management
Any business operating in healthcare should assess its liability in selling products and providing services. Liability under consumer protection legislation, negligence claims and contractual claims may arise. Risk management strategies, including robust quality control, appropriate terms of sale or services and adequate insurance, are therefore essential.
Corporate structure
There are several ways to structure a business in the UK, and structuring the business correctly is important. Key constitutional documents and principal agreements between the founders should be put in place at the outset, carefully setting out the rights and obligations of the founders and the investors. These documents will be considered at various milestones throughout the life of the business.
Conclusion
It is exciting to see the pace of change in the healthtech space. It is essential for a healthtech business operating, or looking to set up, in the UK to keep up-to-date with legal developments and navigate the legal and regulatory requirements correctly.
If you have any questions about any matters discussed in this article, please get in touch with Orit Rioumine Gold.
