All kinds of stories concerning healthcare digitalization have been flooding from every outlet for most of the past decade. No wonder then, that sometimes both buyers and users are lost. However, we all can probably agree that digital health care solutions should not be procured without proper understanding of the costs in relation to the outcomes, i.e. one should always demand solid proof of effectiveness.

Like any drug, the effectiveness of digital health care solutions should be proven; it needs to improve treatment outcomes or save on costs, or both. At its best, it improves the functionality and availability of services and reduces the burden on health care.

A functional digital health care solution improves treatment results

The goal of a digital health care solution is usually to streamline or enhance treatment pathways; when the path is smoother and more effective, the patient receives better care and health care resources are allocated more rationally. For example, the patient may perform PEF or INR monitoring remotely, and the information is automatically transferred to his or her own caregiver. The patient receives immediate feedback if needed. No ambiguous records, no trips to the lab, less staff input – in short, better care and better treatment outcomes at a lower cost.

What is sufficient evidence of functionality?

In the past, digital treatment options could be marketed without any clinical evidence. Fortunately, the situation is partly changing with the new medical device regulation (MDR) being applied since 26 May 2021: to get the CE marking, a device involved in the care of a patient must show evidence of effectiveness. This clinical evidence also helps HTA authorities in different countries determine the acceptable price.

For example, Orla’s PEF remote monitoring has been used and evaluated in the primary health care in the city of Hämeenlinna. The results show a significant improvement in the use of resources: in the past, about 25% of asthma diagnosis and follow-up visits in Hämeenlinna had to be renewed due to poor PEF monitoring. This problem and waste of resources was virtually eliminated when PEF remote monitoring was introduced.1)

Digi-HTA makes recommendations

Digi-HTA is a vital metric for both manufacturers and buyers. It can be used to reach a consensus on an acceptable input-output ratio and reliability, as well as facilitate the introduction of new solutions. Orla is committed to using the Digi-HTA process to assess the effectiveness and pricing of both already launched, as well as upcoming, treatment solutions.

Long-term development work

Orla DTx is a Finnish company developing digital therapies (DTx), who wants to help health care take advantage of digitalization. “Thousands of patients have already used our INR and PEF remote monitoring solutions. We develop new solutions and we work in collaboration with health care, global pharmaceutical-, diagnostic- and MedTech-companies.”, says Pekka Männistö, Head of Market Access.

1) Tapanainen ja Merivuori. Kohti parempaa astman hoitoa – perusterveydenhuolto merkittävässä roolissa. Duodecim 2019;135:1745–52.