Digital treatment tools can be developed, validated and researched without being made available to patients. During Arendal Week, participants pointed out obstacles related to regulations, procurement, financing, legal assessments and the responsibility for achieving national dissemination.
Caption: The participants agreed on the need, but did not describe a finished model. If documented tools are to reach patients, several actors must collaborate on responsibility, financing and national dissemination. From left, chair Siri Gulliksen Tømmerbakke, co-founder and AI engineer at Vidd Medical, Anders Austlid Taskén, director of Diakonhjemmet Hospital, Kari-Jussie Lønning, general practitioner and chair of the Norwegian Medical Association's professional board, Ståle Onsgård Sagabråten and Director of Health Cathrine Marie Lofthus.
The topic was how digital self-help and treatment tools can be scaled and become part of the health service. The participants had different roles and therefore emphasized different parts of the problem. Towards the end, Lønning said that she felt that everyone wanted to go in the same direction. Lofthus agreed with this.
Falling between research, innovation and implementation
Anders Austlid Taskén described research, innovation and implementation as three different disciplines. While research investigates whether a solution can work, innovation is about making the solution robust enough for reality. Implementation is about getting it out to those who need it.
The problem arises in the transition between these phases. Digital e-health tools often fall by the wayside because they cannot succeed in everything at once. We lack a framework that can take solutions all the way from research to clinical practice, and today no onehas taken clear responsibility for the entire journey from research results to treatment provision.
Taskén spoke about several obstacles to scaling digital solutions. Among them were regulatory requirements, CE marking, the need for capital, demanding tender processes and fragmented ownership.
Kari-Jussie Lønning recognized the problem from Diakonhjemmet Hospital. The hospital has developed three treatment apps that have shown good results in research populations. Since they are classified as medical devices, they cannot be used by anyone other than the study patients until they are CE marked.
She emphasized that the CE marking requirement is there to protect patients by ensuring that the tools are safe.
Lønning further said that the hospital's main task is to treat patients. The hospital is not equipped to prepare all the legal and technical documentation for each tool. She also referred to the current funding. It is largely linked to consultations and treatment at the hospital. The funding system must be adapted if more treatment is to take place at the patients' homes through an app.
– We need the authorities to lead the way and pave the way for innovation and new technology, said Lønning.
The GP called for national assessments
Ståle Onsgård Sagabråten said that all health innovation must be safe and have documented benefits. The solutions should be developed together with patients and clinicians. He recognized the description that useful solutions stop before they become available in regular treatment. The "plough" must plow to both sides – both towards the specialist health service and the municipal health service – with a common goal of ensuring that the services are coherent.
Sagabråten called for a national competition similar to the schemes for medicines and new methods. He distinguished between CE marking and assessment of medical benefit. A tool must not only meet safety requirements, but its effect must also be in proportion to the cost and effort.
He emphasized that the individual GP cannot familiarize himself with all the regulations. Nor can the GP make a separate methodological assessment of each tool. Nor should the municipalities have to solve the task individually. Such assessments must be made at a higher level.
Sagabråten also believed that there is great interest in digital tools. The solutions must be safe, easy to use and fit into the working day. At the same time, the health service must also take care of those who lack digital competence.
These issues were raised in the debate
The points below are a summary of the topics raised by the participants.
• The path from research to national dissemination: Solutions may be developed and evaluated locally without an established path to disseminate them so that the health service – and most importantly, patients – can benefit from them. Lofthus described it as a key task to find out how a solution that works at one hospital or in one municipality can become available in multiple locations.
• Regulations and CE marking: Apps that are classified as medical devices must be CE marked before they can be used by patients. Lønning pointed out that hospitals are not equipped to prepare all the legal documents and meet all the requirements that CE marking of apps requires.
• Procurement: Taskén said that regular tenders are best suited when it is clear what is to be purchased. Innovation often means that the solution must be tested and further developed. In that case, it is very difficult for a purchaser to formulate a precise requirement specification. How can we create a framework that means that a new business does not have to go through a full tender process from day one? It becomes difficult for new companies. Lofthus emphasized that procurement is demanding and that there arequestions about who is going to do this, and how we can elevate something that works locally to a national level.
• Financing: Lønning called for a financing system that is suitable when the patient receives treatment at home, for example self-treatment via an app. Lofthus said that there must also be a mechanism that ensures that the provider gets paid when such a solution is used.
• Legal assessments and privacy: Lønning said that risk analyses and assessments of privacy consequences require a lot of resources. Taskén supported the description that privacy impact assessments and other risk assessments are among the biggest bottlenecks. It is often unclear who has responsibility and ownership, who is motivated to participate in the process, and who will bear the cost. This is both time-consuming and capital-intensive.
• Fragmented responsibility: Taskén described how several actors can be responsible for different parts of the process. This applies to the professional community, IT, budget managers and purchasers. This means that responsibility and ownership can fall between them.
• Lack of support: Sagabråten said that GPs and municipalities should not have to consider implementing all the tools on their own. Lønning called for more guidance, common templates and better sharing of assessments in specialist health services.
• Different digital prerequisites: Sagabråten reminded that some residents do not have the digital competence required. They need to be provided with an offer that takes care of them.
This is how the participants described their responsibilities
Participants described several roles in this work:
• Patients, clinicians and research communities: Sagabråten said that the tools must be developed in collaboration with patients and clinicians. Lofthus emphasized that innovation must occur in the services, not as a top-down process in the Directorate of Health.
• Developers and companies that make the tools: Taskén described the work of classification, certification and CE marking as part of the path to use. Lønning said that hospitals are not equipped to handle this entire process alone.
• Health authorities and municipalities: Lofthus said that the specialist health service must prioritize among, among other things, treatment, research, innovation and ICT. The municipalities must also set their priorities. Lønning also described the health authorities' responsibility for risk and privacy assessments when new solutions are to be implemented.
• GPs: They can recommend and use digital tools in patient processes. Sagabråten said that quality and usefulness must be assessed at a higher level than the individual GP office. Lofthus described the GP as a possible central hub. Patient processes can move between digital services, the municipal health service and the specialist health service.
• The Directorate for Medical Products: Lofthus pointed out that the regulations for medical devices and CE marking are located there.
• Directorate of Health: Lofthus described a possible national role in spreading documented solutions from local to national use. The Directorate is also working on support, funding and a digital frontline.
• Politicians: Bergheim pointed out that health, industry and finance politicians must work together and several parliamentary committees must be involved.
This is what Lofthus said the Directorate of Health should do
Cathrine Marie Lofthus said that the Directorate of Health should be more on the supply side than before and become more outward-looking. She highlighted that they should particularly support GPs and the municipal health service.
She described the following work:
• Involvement: The Directorate is in the process of involving the industry and planning how GPs, health trusts and municipalities will participate.
• National availability: The Directorate is investigating whether they can take on a role as a national body and offer documented solutions through Helsenorge. They are also considering whether they can possibly take on medical and legal responsibility. This was presented as a possibility, not a final decision.
• Financing: The Directorate is working with the industry on financing models. Lofthus said that there must be financing behind the solutions.
• Regulations: Lofthus said that the Directorate is reviewing the legislation for which it is responsible, and that she believed they would find solutions to much of this. CE marking and procurement regulations are outside the Directorate of Health's area of responsibility. For procurement regulations, they must cooperate with other institutions and ministries.
Lofthus said that procurement is probably the most difficult part. The Directorate does not yet have the solution. She did not give a specific deadline for a completed national model. She hoped and believed that the work would have progressed well by the next Arendal week.
Bergheim would follow this up politically
Ragnhild Bergheim said that they are impatient to adopt digital solutions and apps and that Norway must not fall behind. She wanted to follow up on the topic through her responsibility for the health industry for the Labour Party in the Health and Care Committee. The problems affect several policy areas. Health and industry policy must work together. Fiscal policy must also be involved when the topics are exports and procurement. Bergheim also pointed out that digital solutions can give residents of a long country better access to health services. In conclusion, she said that politicians must stay informed. They must monitor where bottlenecks arise and investigate what they can do.
Same direction, but no ready solution
The debate showed a shared desire for useful and documented tools to reach patients more quickly. At the same time, participants described many challenges before this could happen.
Lofthus said that the Directorate of Health cannot solve this alone. Several actors must cooperate. She mentioned the specialist health service, the primary health service, the industry, academia, the Directorate for Medical Products and the Directorate of Health.
The debate therefore not only points to the need for funding and clearer rules. It also shows the need for national coordination of expertise and responsibility throughout the entire process – from research and documentation to procurement, implementation and operation.
It is still unclear who will make national procurements, how the solutions will be financed, and who will take responsibility when local use is scaled up.
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Politicians agree: Patient apps must be included in the health service
The Unit for Health Services Research and Innovation (EHI) at Diakonhjemmet Hospital and REMEDY have developed several documented patient apps that have not yet reached more than the study patients. From left, professor and leader, Nina Østerås, advisor Marie S. Pettersen and professor and deputy leader of REMEDY, Anne Therese Tveter.
