Result card

  • LEG16: How the liability issues are solved according to existing legislation?
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How the liability issues are solved according to existing legislation?

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Internal reviewers: Ingrid Rosian

Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013)

Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (especially (4), (6), Art 13 (1., 3a, 3b).

used as basic documents for a

discussion with experts

For the provision of telemedical services/ STS several different legal regulations have to be followed, like:

  • Occupational laws
  • Hospital legislations
  • Good clinical practice
  • Health telematic law
  • Data protection law
  • E-government law
  • Consumer protection law
  • Signature law
  • E-commerce-law
  • Telecommunication law
  • Copyright/ patent protection
  • Media law

(list not exhaustive)

This means that there is uncertainty which liability limitations exist for what kind of service provision.

 

The 1926/29006/EC is used as a basic document, especially due to the aim (Art 2) for regulating the consumer aspects. Its not a regulation.

Directive 2001/20/EC was used as a basic document for the discussion due to the ”liability” of member states for any investigantional medicinal products.

The liability issues require a certain business plan for the provision of (any) tele-healthcare service, including telephone support.

This means that the patient has to have one single partner to be ”contracted” with. In the usual face-to-face contact with the primary care physician (general practitioner) the care-contract exists between the patient and the physician.

Within a telehealth-structure there are many possible contracts like telephone line company, energy support, software involved, the staff providing the telephone support, a possible company providing a package of structured support including telephone calls, the physician providing the data check/ medication change/other medical services, the server hosting company for the data storage, etc...

Within this structure there is an additional challenge in many countries, which implies a direct (face-to-face) medical care required from the phyiscian and/or other healtcare staff., and which is per definition not the case for any kind of telemedical service. Also the hospitals are responsible to provide the care within the hospital environment.

A national health system or a social insurance could be able to provide telemedicine as a ”service” meaning the provision of being the ”contract head” for all different included services (as listed above). The patient, the GP, the hospital, the software/telecom/other companies are contracted with the health system (national /community government, or social insurance) within a kind of structured program regulating the rights and duties of the contracted partners.

Such a service of the health system could be provided everywhere, even if the patient is abroad (i.e. for holidays), because it is not a direct medical treatment, but a service package including different aspects.

Hardisty et al.{34} point out that There is a fundamental lack of clarity regarding the location of decision making responsibility when the service is spread across multiple providers. This issue has not been addressed in work to date and may require changes in how services are designed and managed, impacting medico-legal frameworks.

 

The 1926/29006/EC is used as a basic document, especially due to the aim (Art 2) for regulating the consumer aspects. Its not a regulation.

Directive 2001/20/EC was used as a basic document for the discussion due to the ”liability” of member states for any investigantional medicinal products.

The liability issues require a certain business plan for the provision of (any) tele-healthcare service, including telephone support.

This means that the patient has to have one single partner to be ”contracted” with. In the usual face-to-face contact with the primary care physician (general practitioner) the care-contract exists between the patient and the physician.

Within a telehealth-structure there are many possible contracts like telephone line company, energy support, software involved, the staff providing the telephone support, a possible company providing a package of structured support including telephone calls, the physician providing the data check/ medication change/other medical services, the server hosting company for the data storage, etc...

Within this structure there is an additional challenge in many countries, which implies a direct (face-to-face) medical care required from the phyiscian and/or other healtcare staff., and which is per definition not the case for any kind of telemedical service. Also the hospitals are responsible to provide the care within the hospital environment.

A national health system or a social insurance could be able to provide telemedicine as a ”service” meaning the provision of being the ”contract head” for all different included services (as listed above). The patient, the GP, the hospital, the software/telecom/other companies are contracted with the health system (national /community government, or social insurance) within a kind of structured program regulating the rights and duties of the contracted partners.

Such a service of the health system could be provided everywhere, even if the patient is abroad (i.e. for holidays), because it is not a direct medical treatment, but a service package including different aspects.

Hardisty et al.{34} point out that There is a fundamental lack of clarity regarding the location of decision making responsibility when the service is spread across multiple providers. This issue has not been addressed in work to date and may require changes in how services are designed and managed, impacting medico-legal frameworks.

Critical
Wilbacher I, Rupel V Result Card LEG16 In: Wilbacher I, Rupel V Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

References