Remote health consulting services and data analysis in clinical decision-making in Estonia need legal bases

Remote doctor’s appointments and consulting services allowed but unregulated

The Estonian Health Insurance Fund (the HIF) enabled remote consulting services during the state of emergency. At the moment, however, remote appointments are not regulated by legal acts. The HIF hopes to add remote appointments to the list of health care services no later than by 01.01.2021.

Until declaration of the state of emergency, remote appointments had not been used for out-patient health services reimbursed by the HIF. The HIF has stated that since remote consultations were very well received by patients, the possibility of distance consulting will be maintained, and the goal is to add it to the list of health care services no later than by 01.01.2021.

At present, however, the state of emergency has expired, and remote appointments are actually not regulated by law. The health services in general are defined by the Health Services Organisation Act as activities by health care professionals for the prevention, diagnosis or treatment of diseases, injuries or intoxication in order to reduce people’s malaise, prevent them from deteriorating health or from developing diseases, and restoring their health. Health services included in the HIF’s list of health care services are reimbursed by the HIF. However, that list does not include remote appointments or telemedicine services, but simply includes out-patient health services in general.

This means that the exact conditions for and means of remote appointments are at the moment carried out according to the best knowledge of healthcare professionals based on the HIF’s guidelines. As the state of emergency has ended, several concerns arise, eg, with regard to basic data protection questions, but also regarding the principles for applying telemedicine solutions. For example, it is unclear when a healthcare professional may offer remote consultation services, and on what legal basis the HIF reimburses the appointment if the state of emergency has ended but remote services are still not on the list of reimbursable services.

Smart telemedicine calls for smart legislation

Estonia’s success story as an e-country calls for consistent development in the area of use of health data. While EU law contains appropriate legal bases for both development and use of clinical decision support systems (CDSS). Estonian law lacks legal basis aimed at allowing big data analysis for clinical decision-making.

Appropriate analysis of health data is unquestionably necessary for providing personalised medicine services and improving treatment quality. The Estonian government has introduced several strategy documents which highlight the importance of preventive and personalised medicine, people-centred healthcare and enabling services based on data analysis. The Estonian Health Information System (HIS) – as well as other national databases containing data concerning health – provides a unique opportunity for Estonia to introduce e-health services based on big data analysis which can benefit both individual patients and society as a whole. This requires adequate legislation for the development and implementation of clinical decision support systems (CDSS).

In theory, Estonian law includes a legal basis for healthcare professionals to process personal data for both planning and provision of healthcare services (§ 4¹ of the Health Services Organisation Act). However, in practice the possibilities to rely on this legal basis are restricted, because specialised doctors can only process the data of patients they have a previous doctor-patient relationship with, and general practitioners will only process the data on their patient list. So this legal basis is not sufficient for using the full potential of HIS data with CDSS. In order to use the vast possibilities offered by the IT world, legislation should provide the necessary means.

Three tips to legislators for immediate action to improve the future of telemedicine in Estonia

There is no doubt that the use of telemedicine services is increasing daily. In order to be a leader rather than a follower, we have some ideas that should be analysed and implemented by legislators:

• Creating a legal basis for use of data stored by national systems: as noted above, the Estonian Health Information System and other national databases containing data on health provide a unique opportunity for Estonia to introduce e-health services based on big data analysis. But this requires innovation in legislation.
• Removing legal obstacles from growth of e-pharmacies: current legislation prevents, rather than encourages, the establishment of e-pharmacies. We have only 2 e-pharmacies, against some 150 in Finland. Regulation for e-pharmacies should be simplified without delay.
• Reimbursement of telemedicine services: the law covers three different lists according to which the HIF reimburses the cost of medicines, healthcare services, and medical devices. If more and more digital services or telemedicine solutions enter the market, it would be wise to establish a separate category for reimbursable telemedicine services/devices. This would encourage companies to invest in R&D, and at the same time improve our public health with innovative solutions.