In telemedicine, clinical consultations, diagnostics, observations, monitoring, treatment and clinical decisions and recommendations are provided on the basis of information and documentation accessed by medical practitioners electronically, for example via video link or smartphone.
This guidance applies to public sector healthcare units, private service providers (including business entities) and private practitioners providing healthcare services remotely by telemedicine.
Requirements for telemedicine providers
Telemedicine service providers must have access to suitable premises and equipment (including telecommunications) as well as appropriately qualified staff. The services must be clinically appropriate and take account of patient safety. Systems used to transmit and store patient information must meet the relevant legal requirements on confidentiality as well as data protection and security. Service providers are responsible for ensuring that the appropriate data protection and security arrangements are in place for the purpose of transferring data and processing personal information.
Important considerations for telemedicine:
Informed patient consent must be obtained.
Healthcare professionals must carefully assess whether the services they provide are suitable for delivery by telemedicine. For example, telemedicine is not appropriate for healthcare purposes, including clinical investigations, where a physical examination is required or for consultations that may lead to the patient’s right to self-determination being curtailed.
Healthcare professionals are also required to assess whether telemedicine is appropriate for the patient as an individual.
The patient must be identified using a reliable method. One such method is ”strong electronic identification”, as set out in the Act on Strong Electronic Identification and Electronic Signatures (617/2009). It must be possible to verify the method used retrospectively.
Practitioners must keep appropriate records and maintain the patient register in accordance with relevant legislation.
Where required, the patient must be given the opportunity for a face-to-face consultation or they must be directed to an alternative service provider.
All telemedicine providers must also meet the requirements set out in the Personal Data Act (523/1999) and the Act on the Electronic Processing of Client Data in Social and Health Care Services (159/2007). For example, telemedicine providers are required to compile and update a self-monitoring plan on their services as set out in the relevant National Health and Welfare decree (2/2015) (thl.fi) (in Finnish).
Private healthcare providers and independent practitioners
Private sector healthcare providers and independent practitioners must be licensed or registered to provide healthcare services (for example as a doctor, nurse or other healthcare professional) as set out in the Act on Private Health Care (152/1990). All licensed and registered healthcare professionals are also entitled to provide telemedicine services under their existing license. They are not required to apply to amend their license.
Any private service providers and independent practitioners, who do not hold a valid license to provide healthcare services, must obtain a license from the appropriate licensing authority for the purpose of providing telemedicine services. Independent practitioners must submit a notification of independent practice, along with the required documentation, to the relevant Regional State Administrative Agency (avi.fi). Service providers must submit a licensing application for the services they provide.
Licensing is granted to service providers who meet the criteria set out in the Act on Private Health Care. Where relevant, conditions may be imposed on the license in the interest of patient safety.
In addition to the standard application documents required for private healthcare service applications, applicants must also attach a service description that includes details of the business concept and operating principles, target audience, the method used to identify patients as well as patient instructions for how to access a face-to-face consultation. The documents required will depend on the nature of the individual application.
Service provider licensing issued by Valvira and the Regional State Administrative Agencies
Valvira grants licenses to service providers operating within the remit of two or more Regional State Administrative Agencies, while the Regional State Administrative Agencies grant licenses to service providers operating within the remit of a single agency.