Code of conduct and frameworks for digital health applications: A UK perspective

JUNE 28, 2019 @12.33PM
Why is it that we don’t have the level of research and evidence behind our digital health interventions that we do for the rest of our healthcare innovations?
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This is because we have innovators who are not part of our work. They do not come with medical ethics and research background. They are technologists who want to create the future, who want to get them now, who want to get them yesterday.

“We have to put the brakes on them, because clinicians are guardians of patients life, well-being and rights. So even if we have to slow the digital future to make sure that the evidence is right, and that is what we must do. That doesn’t mean that we are paralysed. But it does mean that we cannot be rushing headlong, reckless,” said Hassan Chaudhury, Digital Health Lead at the Department for International Trade, Healthcare United Kingdom (UK) when presenting at the recent Telemedicine: 4th Industrial Revolution in Healthcare conference.   

The National Institute for Health Research (NIHR) under the National Health Service, UK, he said spends one billion pounds a year and has a vision to improve the health and the worth of the medical research.

“The goals are to improve the outcomes through advances of research, improve quality of care, drive economic growth – so NIHR will work with industries, companies and provide the opportunities to work with NHS infrastructure to get evidence for innovation.”

“Patients and the public are at the centre – the heart of what we do at the NIHR, the trust and universities where we collaborate. It is a whole systems approach to health research. So, we’re doing well in applied health research, but there are no country, state or nation that can say that they have the same level of research in digital health.”

Checklist or health applications
In 2016, The BMJ released a journal on guidelines for reporting of health interventions using mobile phones (inHealth) evidence reporting and assessment (inERA) checklist which served the working group in the World Health Organisation (WHO).
 
“Even in 2016, when the phrase mHealth was used for digital health, they needed to do a checklist because as the World Bank reported: In 2011 alone – there were 500 mHealth projects. Despite the emergence of hundreds of mHealth studies and initiatives, there remains a lack of rigorous, high quality evidence on the efficacy and effectiveness of such interventions.’”

This year, The Lancet released: The Lancet Digital Health and it exist because of this quote: ‘Despite the promises of digital health, technical advances have so far outpaced the development of ethical and regulatory frameworks needed to ensure their appropriate implementation.’

“Nothing has changed. The technology is far in advance of what we need it to be – for regulation and safety.

Code of conduct for data-driven health and care technology
“In the United Kingdom, we came out with a ‘Code of conduct for data-driven health and care technology. We started with the code of conduct as regulations, policy, frameworks take time. This was created because innovators in this field come from sectors that are not necessarily familiar with medical ethics and research regulation and who may utilise data sets and processing methods that sit outside existing NHS safeguards.

“This is what I recommend for other countries. Be very careful that your innovators don’t proceed so far outside the regulatory framework. If your regulatory framework needs beefing up, so be it – because the alternative is horrible – losing public trust and damaging health.

Code of Conduct
The principles
“We expect innovators and digital health to understand the users, their needs and their context. If you see someone has one of these innovations; Artificial intelligence for example, have they done this work? Could they have answered that question? Can they define the outcome and how technology will contribute to it?

“Are they using data in line with the appropriate guideline for the purpose of which it is being used? So, if we collect data from patients and we say to them that we are using these data only to manage your primary care team – the team that looks after you, and clinically – that means – when you give your consent – you don’t have to give consent again if the nurse takes over for the night shift.

“But if it is only for that, we have to ask for permission to use it again if we want to use it for secondary use – if we want to do some research. That’s the kind of thing that we are very careful about – what’s the purpose?

2. Fair, transparent and accountable of the data being used.
3. Open standards
4. Be transparent about the limitations of the data and how they are going to be used.
5. Show the type of algorithms being developed, the ethical examination of how data is used, how its performance will be validated and how it will be integrated into health and care provision.
“I would like the innovator to generate evidence of effectiveness for the intended use and value for money.
7. Make security integral to the design
8. Define the commercial strategy

“We don’t expect to give it to us for free, but tell us how are you going to make money? Are you going to ask patients? Are you asking the NHS? Is it insurance based? What’s your strategy? Explain? 

There are different things that we do with digital health.
As Hassan pointed out - digital health covers too many things. It covers blockchain, IoT, analytics, precision – it just goes on. We need to stratify what type of technology that we have and what graded evidence that we want.
 
The question that we need to ask ourselves are – do you feel confident that the digital health technology that you see in Malaysia, are going to be safe for your patients, effective, cost- effective for your system to be able to afford? Are there regulatory frameworks, or do you feel that there is a gap that need to be filled? 

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