ARTICLE
13 September 2018

UK Guidance For Developers Of Health Care Software And Technologies

AP
Arnold & Porter
Contributor
Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs.
UK Food, Drugs, Healthcare, Life Sciences
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Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.

In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.

The Code consists of:

  • 10 key principles (i.e., what DH expects from suppliers of data-driven technologies)

These principles outline best practice for safe and effective digital innovations, including defining the user, the value proposition, the commercial strategy, and the type of algorithm being built.

To address data protection concerns, Key Principle 3 mirrors the GDPR regime by requiring developers to be “fair, transparent and accountable about what data you are using“. Key Principle 4 also states you must “use data that is proportionate to the identified user need” in reference to the national opt-out policy, allowing patients to opt out from having their patient data used beyond their direct care.

  • 5 commitments (i.e., what DH will do to support and encourage innovators in health and care)
    • simplifying the regulatory and funding landscape;
    • creating an environment that enables experimentation;
    • encouraging the system to adopt innovation;
    • improving intolerability and openness; and
    • listening to users.

DH is encouraging developers of data-driven technologies to manage risks to the safety and quality of care by signing up to the Code. It will produce a revised version of the Code in December 2018 and seeks feedback from researchers, innovators, the public, and the NHS. The feedback questionnaire is available here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

ARTICLE
13 September 2018

UK Guidance For Developers Of Health Care Software And Technologies

UK Food, Drugs, Healthcare, Life Sciences
Contributor
Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
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