The digitization of healthcare at the Swedish Medtech Summit 2022 - key takeaways

Swedish Medtech Summit 2022 – Stockholm on October 27; this was my first visit to the event having a very topical theme this year: The digitization of healthcare – health data, interoperability and AI. I noticed that similar topics on EHDS and secondary usage of health data were discussed in the same week around Europe (HUS: Artificial intelligence day and World Health Summit 2022 satellite event “Data For Good: How The Use Of Health Data Can Benefit Our Societies.”). Here are some of my main observations from Stockholm.

The AI Act

Carolina Br?nby from Svenskt N?ringsliv went thru what’s coming up.

The AI Act is a proposed European law on artificial intelligence (AI) – the first law on AI by a major regulator anywhere. The law assigns applications of AI to three risk categories. First, applications and systems that create an unacceptable risk, such as government-run social scoring of the type used in China, are banned. Second, high-risk applications, such as a CV-scanning tool that ranks job applicants, are subject to specific legal requirements. Lastly, applications not explicitly banned or listed as high-risk are largely left unregulated.?

As we notice from the official description of the AI Act, it heavily includes the ethical side of AI.?The AI Act also relates to the risk that is typically encountered in medical systems and medical software. EU authorities - due to currently missing standardization - trust that AI(or ML) is still managed via software regulation. In the presentation, there was also noted that there is a contradiction between MDR /IVDR and the AI Act. Still, the Medtech sector cannot get away from the AI Act if and when it will be applicable.?

EHDS & Secondary law

About the European Health Data Space and Secondary use of health data, VINNOVA opened the game with the first EHDS discussion of the day.?It’s a good initiative to share large health data sets for improved healthcare results Europe-wide. The spirit of EHDS and national secondary laws are quite similar. It starts from local national registries and requires that the data is prepared for interoperability. It usually takes more effort to agree and implement new practices in wider forums. I’d put my stakes first on national initiatives and hope to see these realised later at the EU level.?

Our Swedish colleagues are somewhat behind at the national level, which was also stated in Mats Lindgren’s (CEO, Kairos Future), and M?rten Lindskog’s, (AI-samordnare, Stockholms Stad) presentation when statistics of the maturity of healthcare digitalization were presented.

Some of the forerunners in this area are Estonia and Finland. Both Findata and the Estonian Ministry of Social Affairs held speeches on the status of the secondary use of data. Finland has raised the number of audited data environments from none to over five including universities, a hospital and a public company in addition to Findata’s own environment. Progress is slow, but things are proceeding in the right direction. Especially Estonia has been a digitalization example country with the X-Road data exchange ecosystem which is applied to healthcare data as well.?

The atmosphere in the sunny autumn Stockholm was pleasant as always, a lot of law offices in place – definitely, a lot to do for consulting and probably they see money here ??. Privacy and GDPR breaches have already been heavily fined by national authorities. Health data is extremely personal and deserves to be well-treated. No doubt.

Author:

Antti Kaltiainen, CTO, Digious and Innokas Medical. The writer is a member of TC62 SNAIG Software Network and Artificial Intelligence advisory Group