‘Guide to Good Practice for Digital Health Technologies’: The DHSC’s updated guidance
19 April 2021
The healthcare system is unique in that a wide range of regulatory structures overlap. Dealing with people’s health and the sensitive data that is associated with it requires the highest possible professional and ethical standards. As is the case for many organisations who supply the healthcare system, it can be a daunting venture when coming from a sector that is not as familiar with research regulations and medical ethics. There is the potential to fall short of the high standard required; for example, by utilising data sets or process methods that do not fit with existing NHS safeguards.
To ensure external partners can operate with the NHS effectively, and the wider NHS can be fully confident that they are fulfilling their duty to provide the best care to patients and the best value to the system, the Government recently updated its ‘Code of Conduct for Data-Driven Health and Care Technologies’ to expand on the technical assurance, clinical safety and regulation chapters.
Similarly to the original code of conduct, the new guidance is an extremely valuable resource to help innovators, suppliers and manufacturers understand what the NHS looks for when acquiring digital and data-driven technologies, so that these practices can become imbedded in product development ‘by design’. Even for organisations who do not directly supply into the NHS, the guidance provides a useful framework to achieve best practice in digital health technologies.
This blog post breaks down the 12 principles covered in the guide, providing you with key takeaways to help you achieve best practice.
What are the key principles?
1. Operate Ethically
There is concern that increasing use of data-driven technologies, including artificial intelligence (AI), could cause unintended harm if due consideration is not given to issues such as transparency, safety, accountability, and efficacy.
People have the right to know that their data is being used for their benefit and that their privacy and rights are safeguarded. The responsibility for this lies with the innovators. As such, innovators must review the UK Government’s Data Ethics Framework and follow the principles in developing effective, ethical, and safe digital health technologies.
2. Have a Clear Value Proposition
It is crucial that digital health products and services are designed to achieve a clear purpose. Innovators should be clear in articulating the purpose of the product, ensuring that it is deliberately designed to deliver better provision and/or outcomes for people and the healthcare system.
Characterising this value proposition should include thorough research of user needs across the entire life cycle of the product.
3. Usability and Accessibility
Usability is central to the application of health technology, and poor usability is a key source of frustration for clinicians and patients alike.
For more detailed advice on usability, organisations may follow ISO standards related to usability, including:
Innovators should also ensure the product is easy to use and accessible to all users. They should ensure inclusivity, considering the overall digital literacy within the UK, as well as “particular patient cohorts”.
4. Technical Assurance
The product must be appropriately tested and fit for purpose. The DHSC (Department of Health and Social Care) recommend using a structured “assurance plan” that clearly defines the innovators approach to testing, explaining how the data-driven technology will continue to be developed and managed.
5. Clinical Safety
Innovators must make sure that the product is clinically safe to use, demonstrating compliance with the NHS Digital Clinical Safety Standards.
This requires manufacturers to:
- Have a clinical safety management system
- Carry out specific clinical risk management activities
- Maintain clinical safety documentation
6. Data Protection
It is important that innovators can demonstrate that their product collects, stores and manages user data in a safe and lawful manner. In addition to more general data protection legislation, there must also be consideration for the specific rules that apply to handling confidential patient information.
7. Data Transparency
Innovators should be fair, transparent, and accountable about what data is being used.
Making use of tools that ensure complete traceability is key; for example, audit-trail and time-stamped documents for complete traceability and transparency.
Additional points to consider are:
- The transparency limitations of the data used. Assessment of data quality should be continuously checked.
- Good data linkage will mitigate reducing data quality.
- Transparency as to whether an algorithm has been deployed in a real-world clinical implementation or is limited to a training data set.
Industry best practice security standards should be made an integral aspect of the product design. For an example of best practice, organisations should follow the NHS Digital Data Security and Protection Toolkit.
The product must meet all relevant regulatory requirements. If the product is a medical device or in vitro diagnostic tool, there will be additional requirements that must also be considered fully.
10. Interoperability and Open Standards
The product should utilise open standards to maximise data quality and interoperability, with the goal of providing a “seamless care journey”.
11. Generate evidence that the product achieves clinical, social, economic, or behavioural benefits
When designing or developing the technology, consider the function that the product delivers. In turn, this will be able to inform the evidence generation plan. The first step in evidence generation is proving that the product delivers its intended use. Following this, the product must then be validated.
Organisations designing products for national recommendation or procurement can have the product formally reviewed by the National Institute of Health and Care Excellence (“NICE”). A recommendation like this is described as the “gold standard” and would be looked upon very favourably.
12. Define the Commercial Strategy
Innovators should take into account extra considerations when NHS data forms the basis of the commercial arrangements. The DHSC has outlined five separate “guiding principles” to ensure that NHS stakeholders also gain fair benefits from any such agreements.
Ideagen are here to support your organisation meet these best practice guidelines. Our solutions help you put your patient first through improved quality, innovation, productivity, and performance.
Find out more about our healthcare quality management software and how it can help you achieve best practice.
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