Sessions

The focus of this track are approaches to ensure safe and meaningful utility of digital health. It starts with the regulatory perspective, is it a medical device? If so, what does the legislation require?Some solutions will be used directly by individuals without any link to the healthcare system, others will play an integrated role in the healthcare system.For those used either in health or social care, there is a need for methods to ensure the affordability and usefulness in the system to ensure the societal value.

The potential of quality health and wellness apps in addressing European healthcare challenges such as an ageing population and chronic diseases putting pressure on healthcare budgets, unequal quality and access to healthcare services and shortage of health professionals, is widely recognized. Yet consensus on what makes a quality health app has been lacking. Patients, citizens and healthcare professionals do not have the means to recognize the quality health apps. Authorities struggle to efficiently assess health apps and manufacturers are faced with a multitude of frameworks and difficulties to increase uptake and reimbursement. All of the above inspired the European Commission to commission CEN-ISO/TS 82304-2:2021 "Health and wellness apps - Quality and reliability".

“The Nordic Welfare Model is not sustainable!”, they said, ”Too much focus on healthcare and too little on preventative care will break the system going forward. We need to get the citizens more involved, not only in the care process but also in preventative care. The question is just – how?”

The Norwegian project "Safer health apps" has looked at how Norway can increase the uptake of health apps in the society – as part of the national, public health service – and developed a "how-to" guide for quality assessment of health apps and similar technologies.

Digital healthcare technologies (DTHs), including health apps, have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as other healthcare methods. The health technology assessment (HTA) supports decision-makers by producing the unbiased assessments of different type of health technologies. In Finland, the Digi-HTA process supports HTA activities for all types of DHTs, such as health apps, artificial intelligence and robotic solutions. In order to ensure that Digi-HTA would be as compatible as possible with other recognized assessment methods, the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) has carried out a comparison work that includes the DiGA and NordDEC assessment models and the CEN/ISO TS 82304-2:2021 technical specification.

The German DiGA process has raised international interest, with more than 30 digital solutions which has received temporary or permanent reimbursement. In this session there will be an overview of the process and summary of how the insurance companies see the process. What can we learn from their experience?

With an already existing pathway for digital therapeutics (DTx) and a new permanent reimbursement mechanism for remote monitoring, France is becoming the country with the most advanced reimbursement system for digital health. This presentation will give an overview of what these new pathways entail.

France is currently in the process to establish a pathway for temporary reimbursement for digital health solutions, including both therapeutic solutions (DTx) and remote monitoring. This presentation will give an overview of what this new pathway entails.

Remote Patient Monitoring is a crucial tool to create benefits for the patients, the providers and the payer. Yet there are several barriers on an international level that prevents the wider use of the technology, where reimbursement is still one of them. Boston Scientific has worked together with KOL's, patient organizations as well as trade organizations in trying to help solve the reimbursement. Our Health Economy and Market Access (HEMA) department acrosss Europe has managed be a valued partner in the development of reimbursement guidelines for RPM. Please join us in sharing our journey and our insights.

The panel-discussion will focus on the societal perspective of how to ensure introduction of useful and affordable solutions in social / health care?Is there an overlap between evaluation frameworks and the MDR?What type of evidence of usefulness should be required at different stages of implementation?Is there a need to evaluate the effectiveness of implemented solutions in real-life?How do we ensure affordability / cost-effectiveness?