Of all places, Switzerland - the most innovative country in the world - suffers from a shortage of new digital technologies reaching the market in the healthcare sector. Researchers from ETH Zurich have been investigating how innovations can be developed responsibly and implemented faster.
In brief
- Digital technologies have the potential to drive significant advances in healthcare, but their introduction is hampered by a slow and inflexible approval process.
- ETH researchers advocate for a more flexible regulatory environment and the establishment of a new competence centre for digital health in order to provide more targeted support for innovation.
- While the industry is keenly aware of data protection and patient safety, it still often overlooks more complex ethical issues such as the fairness of algorithms.
Calculations by the consultancy firm McKinsey reveal that if Switzerland fully harnessed the potential of digitalisation in healthcare, it could save CHF 8.2 billion a year, which corresponds to just under 12 percent of healthcare spending.
However, alongside these opportunities, digitalisation also poses ethical risks - including in relation to the use of artificial intelligence (AI). If systems of this kind are not trained with sufficiently diverse data, they can discriminate against certain patient groups.
Moreover, anyone seeking to bring a new health technology to the market in Switzerland must be prepared for the long haul, as the approval procedure is both complex and time-consuming. It is hardly surprising, therefore, that innovative technologies such as AI-driven diagnostics or treatment management with wearable devices often appear on the market elsewhere - such as in the USA, whose approval process is more efficient.
In recent years, researchers from the Health Ethics & Policy Lab at ETH Zurich have been investigating how digital innovations in the healthcare sector can be developed and implemented responsibly. As part of a roadmap , the researchers have compiled recommendations for policymakers.
- For innovations to be beneficial for society they must be aligned with ethical principles and deliver tangible benefits to people. They should be accessible to all, alleviate the strain on the healthcare system and promote social justice.
- Digital health solutions must be compatible with one another. This is crucial for enabling secure and seamless data exchange between various healthcare providers, hospitals, computer systems, and applications.
- The most effective solutions emerge when developers, healthcare professional and users work together from the outset on the development of new technologies. This cooperation leads to technologies that fulfil all requirements and can be utilised by all stakeholders.
- In addition to safeguarding privacy and handling personal health data responsibly, developers and physicians need to be made aware of ethical issues.
- While new digital health solutions are emerging rapidly the healthcare sector often lacks flexibility in its regulations and laws. Revision processes for adapting them struggle to keep pace with swift technological development. The researchers advocate for making the approval process more flexible (see interview below).
"We need a competence centre for digital health"
ETH News: Professor Vayena, you led the study and deal with digital health technologies in your everyday work. What level of awareness is there of ethical issues in the sector?
Effy Vayena: The awareness is there, particularly in terms of data protection and patient safety. There's still room for improvement when it comes to more complex issues such as whether algorithms are fair or might reinforce social inequalities. However, ethical issues arise not only during the development phase of a product but also as products are moving to the market. At present, the market access process in Switzerland is cumbersome and not well suited to digital innovations.
Why is that a problem?
It goes without saying that the authorities cannot allow an unsafe product onto the market. At the same time, however, safe and socially valuable innovations should not be subject to unnecessary delays. I'm talking about products that benefit patients or that allow improvements in efficiency, thereby reducing healthcare costs. Examples include AI solutions for physicians and hospitals or wearables to manage therapies. However, the current market access procedure for such applications is slow in Switzerland.
How can this process be improved?
Technology is advancing at a rapid pace, particularly when it comes to AI. We need an efficient market access process that adapts quickly, and that can therefore keep pace with technological advances. Our work brought the full range of stakeholders together: engineers, investors, physicians, representatives of patients and regulators. Together, we discussed the idea of agile regulation and made concrete proposals. This includes, for example, experimental approaches such as isolated test environments, which allow new technologies to be tested safely and regulations to be updated on an ongoing basis. Innovation can therefore be promoted without neglecting patient safety or ethical standards. This allows for innovation happening not only in technology but also in regulatory process.
What could agile regulation look like in practice?
We propose establishing a competence centre for digital health - based within existing regulatory authorities and drawing on interdisciplinary expertise from the worlds of medicine, ethics, technology and law. A centre of this kind would pave the way for more intensive collaboration between regulators, engineers and scientists. Whereas, at present, innovators don't begin the market access procedure until they have a finished product, this type of centre allows innovators and regulators to begin collaborating during product development. Technological development and regulation could therefore proceed at the same pace. This would be a huge opportunity for Switzerland, allowing the country to play a leading role and chart its own course. The benefits would extend beyond just the industry and the healthcare system; patients would gain significantly, and with them all of us.
About
Effy Vayena is a professor at the Department of Health Sciences and Technology of ETH Zurich. As a bioethicist, she deals with ethical and political challenges in the areas of AI, digital health and precision medicine.
