On 30 November 2022, the Association of British HealthTech Industries (“ABHI“) hosted its annual conference. The focus was on how the NHS and regulators are developing and implementing legislation, processes and infrastructure to create an innovative environment for HealthTech in the UK to support patients and the health system.
We have highlighted our key takeaways below – these will be essential considerations for any organisation involved in HealthTech, particularly connected devices, data analytics, health apps or clinical decision support systems.
- Healthcare data’s potential: Many speakers at the conference highlighted the significant value of data in the healthcare space. The UK in particular was emphasised as sitting on a “goldmine of data” and it was noted that data is a “national asset” to improve health services. Utilising this data can help bring to market new medicines, vaccines and other vital tools to market.
- Privacy is a priority: As healthcare data’s potential is unleashed, privacy must remain a priority for both innovators and regulators. In addition, it was noted that data and AI can lead to inequality in health and social care. Innovators and policymakers were reminded of these considerations which all stakeholders need to keep in mind as the industry moves forward and new technologies are developed.
- Transparent regulation: There is a need for regulation in this area to be transparent. This is crucial to retain the public’s confidence in both innovators and regulatory bodies.
- Reliance on guidance: Academic researchers in this area emphasised the need for regulatory reform around AI as a medical device to be light-touch and rely heavily on issuing guidance rather than enacting large amounts of legislation. A speaker from the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA“) agreed and indicated that this is the approach the government intends to take.
- Global focus: The MHRA is keen to reform its approach in this area to adopt a global focus and to align its approach closely with organisations such as the FDA in the USA. Speakers also expressed their desire for the UK to become a world-leader in this field, given its significant potential.
Organisations involved in the HealthTech industry should be sure to consider the changing regulatory landscape in this area. The above takeaways provide a helpful indication of the NHS’s and regulators’ priorities which will shape the industry going forward.
The ABHI website can be accessed here.