On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here).
The Standard, which is based on existing industry and health standards, is intended to streamline how digital health technologies are reviewed and commissioned by the NHS and social care.
The Standard contains ten components that developers of digital health technologies should adhere to:
- review, and adhere to, the Code of Conduct for Data-Driven Health and Care Technologies (available here);
- ensure that the product is designed to achieve a clear outcome for users of the system;
- ensure that the product is easy to use and accessible to all users;
- ensure that the product is clinically safe to use;
- ensure that the product collects, stores and processes users’ information in a safe, fair and lawful way;
- ensure that the product meets industry best practice and security standards;
- ensure that the product meets all regulatory requirements;
- ensure that the product makes the best possible use of open standards and complies with all relevant technical standards;
- ensure that the product is appropriately tested and fit for purpose; and
- generate evidence that the product achieves clinical, social, economic or behavioural benefits.
The Standard also observes that many digital health technologies will be subject to commercial arrangements between NHS organisations and commercial parties, and states that where those arrangements involve NHS data, they should adhere to the principles described in Creating the right framework to realise the benefits of health data (available here). The Standard also emphasises that legal advice should be obtained in respect of the contracts governing these arrangements.
Feedback from the Consultation will contribute to the final draft of the Standard which is currently set to be published in “Summer 2020” and will be subject to annual updates.