Europe’s regulatory framework needs to keep pace with innovation in healthcare

Covid-19 has seen more innovation in digital healthcare than ever before. But are governments and insurers prepared from a regulatory perspective?

Since the Covid-19 pandemic first hit Europe in 2020, the number of medical consultations undertaken via telemedicine has hit record levels.

This increase has been an unexpected catalyst for the development of telemedicine, now widely viewed not merely as a fad or temporary replacement for face-to-face consultations, but as a core element of primary healthcare moving forward.

According to Eva Kaili, an MEP and member of the European Parliament’s Industry, Research and Energy Committee, the number of digital health apps available in the EU has jumped from around 90,000 in 2020 to more than 350,000 today.

However, the increase in use of not just telemedicine but many other digital healthcare solutions raises a number of issues, including access to medical records, data privacy, cybersecurity, and the reimbursement – by either public or private insurers – of payments for digital health services.

Existing regulatory frameworks – particularly public health funds which have little or no provision for the reimbursement of the cost – often don’t cover digital solutions, meaning that governments and pan-national institutions have had to scramble to incorporate new technology, with mixed results.

But what it certainly has done is to concentrate minds among key stakeholders on the fact that healthcare will look a lot different in the post-Covid-19 world, and that they need to prepare for the coming changes.

The largest digital health market in the world

One leading healthcare expert in the emerging Europe region, who asked not be named due to his current affiliation, explains the transformation that is now taking place.

“Before the pandemic, there was reticence in adopting digital solutions,” he says. “A start-up would approach a key regulatory stakeholder, a national health fund, an insurance company, a regulatory body, and would be met with nonchalance. The start-up would time and again be told the same thing: ‘Great, another digital idea. We like it, but it will take time to insert it into our regulatory system, it will take many years.’ Covid-19 has changed that mentality.”

This is one of the few positive outcomes of the pandemic, and should not be underestimated, he says, adding: “this trend is going to save a lot of lives.”

One of the European-level responses to the increase in digital health solutions has been the European Common Health Data Space (EHDS), which aims to provide a common framework across EU member states for the sharing and exchange of quality health data such as electronic health records, patient registries, and genomic data, in order to support healthcare delivery, but also to facilitate health research, policymaking, and legislation.

The EHDS is expected to be adopted by the European Commission in the first quarter of 2022, following extensive public consultations earlier this year. A recent report by EIT Health’s think tank suggests that implementing it will be a challenge across Europe, not just in its emerging regions.

Among its recommendations, it says that “digital health solutions which show a positive healthcare effect via a controlled study in one member state should be able to enter reimbursement schemes in other member states. This would reduce the challenges of reimbursement, drive innovation, support healthcare systems and could develop the EU into the largest digital health market in the world.”

In 2022, EIT Health InnoStars will run a series of round table discussions in Central, Eastern and Southern Europe to map prescription opportunities of digital therapeutics and digital health applications.

Jaanus Pikani, chairman at the life and health science meta-cluster ScanBalt, and a board member of the Tartu Biotechnology Park in Estonia, says that Covid-19 led to a speeding up in discussions regarding the EHDS.

“The acceptance of digital health applications, including teleconsultations, is at much higher levels than it used to be. I think that a lot of governments have now realised that they need to accelerate the use of these services,” he says.

However, not all adoption of digital solutions has been brought about solely by the pandemic.

Radosław Sierpiński MD, PhD, president of the Medical Research Agency in Poland, says that digital solutions were being implemented even before the pandemic, but admits that during Covid-19, the use of telemedicine solutions has significantly accelerated.

“In the near future, the Medical Research Agency will make a significant contribution to the development of this area, searching for new solutions and implementing them in the health care system,” he says.

Solutions now, not in the future

Kristaps Krafte, founder and CEO of Vigo Health, a Latvian start-up that offers a digital rehabilitation programme for stroke victims which can be used at home by anyone with a tablet and is suitable for users with no technological knowledge, agrees that Covid-19 has had a huge impact on healthcare systems around the world, primarily because of the realisation that new solutions need to be implemented as soon as possible.

“This has never happened before, and it is all because of Covid-19,” he says. “They can no longer play the long game, they need solutions that can be implemented not in a year’s time, but in a month’s time.”

Matej Adam is a digital health strategy consultant at the National Health Information Centre in Slovakia, and says that before Covid-19 the willingness of innovators to take risks was influenced by the conservativeness of the relevant authorities (governments, regulatory frameworks), but that the pandemic brought home the need to get things done faster.

However, he suggests that in Slovakia and Czechia at least, little has changed. “Things are still being done in long cycles, there’s no agility.”

Nina Sesto, director of digital health at the Magdalena Clinic for Cardiovascular Medicine in Croatia, reports more positive developments from that country, however.

“In a matter of weeks [following the outbreak of the pandemic], the government launched a digital health assistant that helped you understand if you might have Covid. It was all automised. This had never happened before for any disease,” she says.

Cheap and scalable

One of the reasons for this, she suggests, is a realisation that there are savings to be made.

“Digital health is in fact cheap, and it is super scalable,” she adds. “Sometimes, very simple solutions can have a tremendous impact on the quality of service, on the triage of patients, on much better planning when a patient needs to come to the hospital.

“At the end of the day, this all reflects in the cost side of healthcare and this should be the interest of the governments, of the whole healthcare system because across our region countries are battling with the skyrocketing costs that are accumulating on a monthly basis. Digital healthcare is a great tool to control the cost side of healthcare by efficiency.”

Even in Romania, where according to Razvan Mircea Chereches, chair at the department of public health at Babes-Bolyai University in Cluj, the government had long been resistant to reimbursing the costs of digital healthcare solutions such as telemedicine, there is finally some change.

“Even during the pandemic, the authorities resisted and continued to resist for a year until they figured it out that this will not end soon,” he says. “Now we start to see some protocols in place, a structure for reimbursement. You can see how things are adjusting.”

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