Digital Health And AI Best Practices For Policy Makers: A Free Report

Regardless of how advanced our healthcare technologies are, no matter how well-educated our doctors are, or how digitally literate our patients become, without a robust and supportive regulatory framework, progress can only go so far. In essence, the true effectiveness of digital health technologies hinges largely on the strength of the regulations in place. No matter how groundbreaking these innovations might be, their potential can be undermined if the regulations aren’t up to par.

Click here to download the report

Thus, the continuing digital health and AI revolution depend fundamentally on our policymakers. It is important to understand that weak or non-existing regulatory frameworks will not stop tech adoption, it will urge patients to take matters into their own hands and start using available technology anyways. The #wearenotwaiting movement of diabetes patients perfectly illustrates what happens in such an environment.

Recognising the vital role of policymakers in shaping the landscape of digital health, we’ve put together this comprehensive free guide. Our goal is to inspire and inform those who have the power to drive change with examples of best practices already in place around the world. Our aim is to show that there’s no need to reinvent the wheel, as there are many tested and successful solutions just waiting to be discovered and implemented.

We’ve made this guide freely accessible because we believe in the power of shared knowledge and learning from each other’s successes.

A double paradigm shift is breathing in our necks

We know that healthcare is on the verge of a paradigm shift. The doctor-patient relationship is changing due to digital health technologies, patients are becoming (supposed to become) partners in their own care, delivering valuable data and insights to the medical team.

But before we have even internalized this trend, we need to welcome another new member to the care team: artificial intelligence. The centuries-old notion that the source of ultimate medical knowledge resides in the heads of medical professionals is disappearing.

Moreover, with the rise of lifestyle diseases like diabetes and obesity, healthcare costs are projected to escalate even further. As humanity can manage chronic diseases with increasing efficiency, life expectancy increases, paradoxically leading to even more severe shortage in healthcare access.

Responsible governments prepare for this change

In such turbulent times, it is the responsibility of regulators and policymakers to keep all stakeholders in line in order to truly leverage the potential of technologies for healthcare and avoid dystopic outcomes. It is a difficult task to undertake. Governments should listen to people, technology companies, drug producers, healthcare providers and shape policy according to real needs while keeping pace with innovation. Policymakers must find a balance between safety and innovation. They should promote the safe use of digital health technologies while offering regulations to separate the wheat from the chaff. Besides, they should think about all the potential legal consequences of the usage of healthcare technologies, including data protection.

Fortunately, several governments are already consciously preparing for the future. Canada, New Zealand, Denmark or Estonia are on the way to an entirely digital healthcare system – every one of them being at a different stage of development, delivering already implemented good practices for other nations.

Recognizing that issues vary across countries, regions, and medical specialties; we have strived to include as many exemplary cases as possible in this policy report. They are grouped together around the four most important topics: 1: patient design replacing patient centricity, 2: the regulation of digital health, 3: national policies and 4: regulating AI.

Let’s see a few examples from the report!

Patient design vs patient centricity

A paradigm shift is underway in the patient-clinician relationship, driven by irreversible changes in information access, yet the model under which clinicians are trained, care is conducted, and care delivery is designed has not changed significantly even though we call it “patient-centered.” It is increasingly important to understand the crucial difference between patient design and the illusory “patient-centric” approach that keeps patients in passive roles and means nothing more than “we might think about you when we make decisions”.

Patient design is a different concept, one that invites patients as active participants – and stakeholders – in the highest levels of decision-making in healthcare. This is called a “co-design” approach and is defined as “a creative practice that can be used to improve customer experience and enhance value”.

To build this new world of practice and workflow, we simply must engage with patients as true partners. To achieve medicine’s new potential, it must be optimised around the wants and priorities of the ultimate stakeholder—the party that has the most at stake in how it all plays out: the patient. Patient design is the approach that can make it happen.

Regulating digital health – how to handle digital therapeutics

Digital health applications and solutions are increasingly becoming part of our healthcare experience. Partially because they offer fast and convenient solutions for problems arising from capacity shortages of traditional medical systems (like skin-checking apps), or because they enhance the capabilities of doctors, medical personnel, or hospitals (like sepsis watch algorithms or AI diagnostics models).

While these apps are available in many medical specialties, channelling them into state-run healthcare systems to harness the benefits on population-wide scales is challenging. Germany’s DiGA system tackles this issue.

Based on the Digital Healthcare Act, 73 million Germans covered by statutory health insurance (approximately 90% of the total population) are entitled to use DiGAs, provided they have a prescription or an attested diagnosis. This means that digital healthcare has made it into primary care.

Statutory health insurers reimburse the associated DiGA costs, with prices negotiated in advance with the umbrella association of German health insurance companies.

National policies – New Zealand gets outside input into government policy

The Government of New Zealand has a public health strategy, a health technology strategy and they invited people to give feedback on the upcoming digital health strategy too. They create the report with the digital health sector through literature review, briefings to sector groups, face-to-face workshops and online collaboration.

Their opinions will be incorporated into the final report and will be published under a Creative Commons license meaning that anyone can freely access them.

The Strategy is not meant to be a detailed plan, nor a document to sit on a bookshelf, but aspirational goals and enabling strategies, priorities, frameworks, guidelines and resources that will evolve and change over time in response to the changing digital world that New Zealanders live in.

They also expect continual revision of the Strategy as the digital future emerges, which is an excellent approach to address the changing needs of patients.

Regulating artificial intelligence – Large language models

The rapid progress in artificial intelligence (AI) has given rise to advanced large language models (LLMs) like GPT-4 and Bard. These LLMs have already gained significant interest in the realm of healthcare due to their wide-ranging use cases such as aiding in clinical documentation, expediting insurance pre-authorization, summarizing scientific studies, and functioning as chatbots to respond to patient inquiries about their personal data and worries.

Despite their immense transformative potential, it’s crucial to approach LLMs with caution. Their training methodology differs from other AI-powered medical technologies that have already undergone regulation, a distinction that becomes particularly significant in the sensitive arena of patient care.

The latest iteration, GPT-4, introduced in March 2023, escalates the potential and risks of this technology in supporting various medical tasks. Alongside the inherent risks of misinterpreting its outputs due to inconsistent reliability, GPT-4 showcases advanced capabilities such as interpreting text within images and analysing their context.

The task of regulating GPT-4 and other generative AI in the healthcare sector without stifling their revolutionary potential is a pressing and critical challenge. This is necessary to ensure patient safety, uphold ethical standards, and safeguard patient privacy. We propose that regulatory supervision should reassure medical professionals and patients of the safe use of LLMs, without jeopardizing their data or privacy.

There are many more great examples in The Medical Futurist Institute’s report. Please feel free to download it and share it with anyone who might be interested. We encourage you to send it also to your policy-makers if you think that more should be done with regard to healthcare policy in your country. We hope everyone will get access to digital health!

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