HealthTech law: AI, medical devices and digital

Artificial Intelligence (AI) has the potential to significantly improve the performance of the healthcare system, supporting a move towards the goal of better patient care, improved diagnostics and more efficient processes.

As healthcare data is opened up to artificial intelligence we help clients navigate the complex legal and regulatory frameworks that currently exist and demystify some of the common concerns regarding the use of AI.

We have advised clients on the data protections and public law principles underpinning the lawful use of AI, the governance arrangements that should be put in place for its use, and drafted AI use policies so that staff properly understand the parameters of using AI in the workplace.

Our specialist team can help you implement the requirements of the data protection legislation. We advise on the day-to-day use of personal data related to employees, patients or other people, through to some of the very sensitive privacy and sharing issues which all organisations in the health sector face.

We have extensive experience advising on privacy issues associated with apps, research projects and sharing across international boundaries. More recently, our work has involved looking at duties and obligations related to cloud-based storage and anonymisation to enable learning to be shared across the health sector.

What we can do for you:

• Information law policies review: Undertake a thorough review of your information law policies and procedures to make sure you comply with Information Commissioner’s Office guidance and health specific legislation.
• Data protection obligations: Assist you in meeting your data protection obligations to specific data subjects, including employees, patients and whistle-blowers.
• Data sharing risks: Advise on risk areas of proposed data sharing relationships with third parties and how to mitigate these risks through robust diligence and written contracts. This includes advice on undertaking and completing Data Protection Impact Assessments.
• Data sharing policies and agreements: Developing clear policies and agreements on data sharing and anonymisation for wider sharing within the system for learning and research purposes.
• Training: We’re also happy to provide bespoke training to you on any data protection issues that may be useful. This training can be provided in a format that works for you.

We guide clients through the regulatory landscape early in the development of new products or business structures and help respond to regulatory challenges that carry significant risks to the business. We can:

• MHRA licensing and registration: Advise on MHRA licensing and registration requirements for medical devices and assist in the process.
• Intellectual propert (IP) law: Protect any IP rights
• Startups: Supporting HealthTech and other startups in the life sciences sector with our novel Grow package to enable entry to the UK market from corporate advice and company incorporation, to preparing supply agreements for the NHS.
• Incidents and investigations: Provide urgent and responsive advice for incidents and investigations.
• Contract law: Review contracts to ensure that they protect your business from regulatory liabilities.
• Training: Provide training on how to deal with inspections by a range of regulators.