Where should the line be drawn when deciding whether or not to adopt disruptive technologies? As digital health brings up plenty of ethical questions, legal issues, and safety concerns, The Medical Futurist Institute decided to collect the best examples of how governments worldwide tried to adopt digital health. We hope it inspires other policy-makers to take the first steps in shaping their healthcare regulations.
Disruptive technologies spread around like wildfire, but healthcare systems are crumbling under the pressure of problems and changes. So, The Medical Futurist Institute is eager to do what it can to make sure we arrive at the envisioned better future of healthcare. Our collection of best digital health policy practices, Digital Health Best Practices For Policy Makers, is available and accessible to everyone for free and we encourage everyone to use it for the common good.
We know that healthcare is on the verge of a paradigm shift due to the appearance of technologies such as artificial intelligence, health sensors, robotics or 3D printing. Accessibility to information and knowledge and the availability of technological solutions outside healthcare lead to change in the doctor-patient relationship as well as in the fall of the “ivory tower” of medicine. The centuries-old notion that the source of ultimate medical knowledge resides in the heads of medical professionals is disappearing.
Transformation is also fueled by the fact that healthcare systems have more and more problems and the old methods do not bring the expected solutions. The World Health Organization estimates that there is a worldwide shortage of around 4.3 million physicians, nurses, and allied health workers, and care is often unavailable where it is most needed. Worse, with civilizational diseases like diabetes and obesity on the rise, healthcare costs are expected to grow even faster. American health spending will reach nearly $5 trillion, or 20 percent of GDP by 2021. The current practice of medicine is simply unsustainable.
In such uncertain times, it is the responsibility of regulators and policy-makers 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.
Luckily, there are already a handful of governments consciously preparing for the future. Canada, New Zealand, Sweden or Estonia are on the way to an entirely digital healthcare system – every one of them being at a different stage of development. Moreover, issues vary over countries, regions as well as medical specialties, so it is difficult to draw lessons and generalize. In spite of it, The Medical Futurist tried to come up with as many great examples as possible in its policy report. They are grouped together around the four most important topics being patient centricity, the regulation of disruptive technologies, appropriate responses to ethical challenges and the promotion of the use of digital health.
The patient-centric approach is really at the heart of digital health, because patients are becoming more empowered, and they are assuming a greater role in their care with new technologies. Therefore institutions that incorporate patients into their thinking merit recognition for spurring others to do so. No matter whether it’s about a regulatory agency inviting patients to participate in shaping policies or a medical facility including laypeople in designing its hospital rooms.
Look at a great Danish example! One of the greatest frustrations for patients is the inability to contact their doctor without going through a lengthy phone attempt or going through layers of staff. It’s hard to define what kind of communication should take place via emails, therefore, it’s worth talking about this openly during in-person visits. To solve this, it is compulsory for all physicians in the Danish primary care services to offer their patients communication via e-mail. Launched fifteen years ago, the public national health portal (Sundhed.dk) is a successful provider of health information, access to medical records and medication, while providing an overview on Denmark’s healthcare system and linking the existing data sources to an easy-to-use, world-leading eHealth portal.
The development of innovative technologies should be guided by an appropriate regulatory framework as the vast majority of people accepts novelties if some quality and safety guarantees are in place. Moreover, technology companies can also work more efficiently if they can adjust their operation to a stable policy framework.
Look at exoskeletons and regulators in the US or Germany! A motorized exoskeleton designed to help people with lower body paralysis won clearance from the FDA to market the device in the US, according to a company and FDA’s statement. ReWalk Robotics’ device is designed to help people with spinal cord injuries stand upright and walk. Similarly, Germany’s national social accident insurance provider, Deutsche Gesetzliche Unfallversicherung (“DGUV”), approved the rental of ReWalk Personal exoskeleton systems for qualifying beneficiaries. Additionally, DGUV also approved the supply of exoskeleton systems for qualifying beneficiaries on a case-by-case basis.
Who is to blame if a smart algorithm makes a mistake and does not spot a cancerous nodule on a lung X-ray? Who will build in safety features so A.I. will not turn on humans? Where are the boundaries for applying gene therapies? Who should have access to DNA tests and personal health data? A swarm of questions and concerns arise from the appearance of digital health technologies, for which regulators should find the appropriate response. But it’s far from easy.
Consider direct-to-consumer (DTC) genetic testing. When they were introduced to the market in the 2010s, it seemed those companies claim more than what they can deliver regarding quality and accuracy. Thus, in 2013, the FDA shut down all DTC genetic services. There was an expectation that it would soon provide a regulatory framework for such services. In 2017, one of the companies, 23andMe, was allowed to market tests that assess genetic risks for 10 health conditions, including Parkinson’s and late-onset Alzheimer’s disease.
In 2017, the FDA also proposed to ease the approval process for such tests. It said that the diagnostics can increase consumer engagement in their health. They said the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers without sacrificing the assurances offered by FDA oversight.
Governments and regulatory agencies have a huge role in shaping people’s attitudes and approach towards technologies and innovation in general. If adoption of novelties is not hindered but facilitated by institutions, positive change is more likely to happen.
In 2017, the British National Health Service (NHS) rolled out a program that encourages physicians to prescribe apps for their patients with chronic conditions such as chronic obstructive pulmonary disease (COPD) or gestational diabetes. The apps can transmit patient data from a tablet or smartphone directly to clinicians. A two-year trial at the Royal Berkshire NHS Foundation Trust found that the system reduced the number of patient visits by 25 percent.
Andrew Lansley, the Health Secretary, has compiled a list of hundreds of apps and online tools. The NHS will recommend these after a public appeal for the best new ideas and existing mobile phone apps. Primary care physicians then will be asked to recommend apps that are free or cheap for their patients to use, in an attempt to give patients more power and reduce visits to doctors.
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 regards to healthcare policy in your country. We hope everyone will get access to digital health!