On the day we published our blog on virtual wards, which included an overview of the UK and EU approach to deployment of technology in healthcare, the MHRA launched its call for evidence on regulation of AI in healthcare. This particular call for evidence relates to AI used in medical devices (including standalone AI as a medical device).
Why this matters
As those in the sector know, AI is already transforming healthcare from drug development, to diagnostics and operational efficiencies. The current regulatory framework does not specifically deal with the use of AI, and with the drive towards digital healthcare the MHRA is seeking to find the right balance between robust safeguards and promoting adoption.
So to support this goal, the MHRA has established the National Commission on the Regulation of AI in Healthcare which brings together experts from technology, healthcare, law, patient groups, the public, government, and the NHS. The National Commission will consider the responses and some key questions about how AI should be regulated, and publish its recommendations later this year.
Who should respond
The MHRA is inviting views from all stakeholders, including:
- Patients and the public;
- Charities;
- Health-tech companies and industry bodies;
- Healthcare providers and professionals, whether NHS or independent;
- UK and international healthcare regulators.
The questionnaire itself asks a number of questions with scoring options, as well as free text to provide additional information.
Key questions include:
- Are current regulations adequate for AI in healthcare?
- How can we improve the current regulatory framework to enable safe, rapid access to AI health technology in the NHS?
- Who should be accountable when things go wrong?
This call for evidence presents a unique opportunity for stakeholders to share their view and help shape the future of healthcare innovation.
The deadline for responses is 2 February, via this link.
Our perspective
This is a potentially pivotal moment for life sciences and health-tech businesses. Regulatory clarity will be essential for innovation, investment, and patient trust. For those organisations developing or deploying AI in healthcare, now is the time to make your voice heard.
If you would like help preparing a response or understanding the implications for your business, please get in touch with either our Health and Care or Life Sciences teams.
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