Data obtained from public sources. Data sent for review to country expert(s), although not all data has been reviewed by country experts.
For questions and feedback write an email to ecan@goeg.at
Last Update: July 5, 2024
COUNTRY INFORMATION – LEGISLATION
AUSTRIA
Austria has no specific legislation on telemedicine, cancer prevention or eHealth applications in cancer care. Note that where no specific legislation is in place, commonly, general legislation is applied. In the case of Austria, for example, the general legal framework for digital health is provided, among others, by the Health Telematics Act of 2012.
BELGIUM
The ‘Law on Telemedicine’ (Wet op Telegeneeskunde, 2018) provides details on the use of telemedicine. Belgium does not have specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation.
BULGARIA
Bulgaria’s ‘Law on Electronic Management’ does not detail the use of telemedicine. The country lacks specific legislation on cancer management and eHealth applications in cancer care, relying instead on general legislation in the absence of specialised laws. This gap highlights the need for tailored regulatory frameworks to address the complexities of telemedicine and eHealth in cancer care.
SWITZERLAND
Switzerland has no specific legislation on telemedicine or eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation. In the case of Switzerland, for example, the general legal framework for digital health is provided, among others, by the Federal Acts on the Electronic Patient Dossier and on Electronic Identification Services. Existing legislation on cancer prevention (as well as early detection, treatment, and aftercare) at national level is only partially established.
CYPRUS
Cyprus has an existing regulation and evaluation process for telemedicine (Electronic Health Law of Cyprus (No.59(I)/2019). There is no further information on specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is commonly applied where there is no specific legislation.
CZECH REPUBLIC
Specific legislation about the use of telemedicine is planned or under development in the Czech Republic. Currently, the topic is regulated only by general rules like Act No. 372/2011 Coll., on Provision of Health Services, and Decree No.: 98/2012 Coll., on Health Documentation. The country has no specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is commonly applied where there is no specific legislation.
GERMANY
The Gesetz für sichere digitale Kommunikation und Anwendungen im Gesundheitswesen provides details on the general use of telemedicine in Germany. The Cancer Screening and Registries Act (2013) is the specific legislation on cancer prevention. The country does not have specific legislation on eHealth applications in cancer care, but general legislation is commonly applied where there is no specific legislation.
DENMARK
There is a basic regulatory framework relevant for the use of telemedicine in Denmark that depends on diverse intertwined regulations like Vejledning om ansvarsforhold m.v. ved brug af telemedicin mellem sundhedspersoner or Bekendtgørelse af lov om autorisation af sundhedspersoner og om sundhedsfaglig virksomhed. The country has no specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is commonly applied where there is no specific legislation.
ESTONIA
Estonia has specific legislation on telemedicine and cancer prevention. The country does not provide information about specific laws for eHealth applications in cancer care. However, general legislation is usually applied in the absence of specific legislation. In 2014, the government approved two green papers on alcohol and tobacco policy as well as a white paper on reducing illegal drug use. Following the adoption of these papers several policy measures have been implemented.
GREECE
The basic legal framework governing the general use of telemedicine in Greece is Law 3984/2011, article 66. With another Law in 2019, the Greek Government established the Hellenic National Cancer Institute (HNCI), supervised by the Minister of Health, that coordinates and assists different aspects of cancer treatment and prevention. The country does not provide further information about specific legislation on eHealth applications in cancer care.
SPAIN
In Spain telemedicine is regulated by Royal Decree 81/2014 of 7 February, which refers to cross-border medical care. It is also mentioned in the Code of Ethics and in the Law on the Organisation of Health Services. The country has no specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is commonly applied where there is no specific legislation.
FINLAND
In Finland, requirements for telemedicine providers are defined in the Act on the Electronic Processing of Client Data in Healthcare and Social Welfare. On the other hand, several legislations refer to cancer prevention such as the Governmental Decree on Screening 336/2011 and the Health Care and Tobacco Acts. There is no further information on specific legislation on eHealth applications in cancer care.
FRANCE
The decree of 19 October 2010 defines five medical acts that can be performed using telemedicine and conditions for implementation. On the other hand, Decree 2021-119 of 4th of February 2021 defines the ten-year cancer control strategy provided for in Article L. 1415-2 1 A of the Public Health Code. Finally, the legislation for eHealth applications in cancer care is part of the above-mentioned cancer control strategy incorporated into the Public Health Code.
CROATIA
Telemedicine is explicitly recognised in various Articles of Croatia’s Healthcare Act as well as in various Articles of Ordinance. There is legislation in the country that explicitly refers to cancer prevention like the National Strategic Framework against Cancer until 2030. There is no specific legislation that refers to eHealth applications in cancer care, but the National Strategic Framework against Cancer until 2030 refers to plans for eHealth cancer care solutions in point 11.
HUNGARY
New specific legislation on eHealth and telemedicine is planned or under development in Hungary, but there are previous laws that already address the topic such as Decrees 60/2003, 9/2012, 39/2016, and Law Act XLVII of 1997. The country also has specific legislation on eHealth applications in cancer care, but it does not provide further information about legislation on cancer prevention. Usually, when there is no specific legislation in place, general legislation is applied.
IRELAND
Ireland has no specific legislation on telemedicine, however, there are several legislative and regulatory schemes which apply to the practice of virtual medicine, such as consumer and data protection by way of general application, and tailored legislation for medical professionals. An example of this is the Health Act 2004 and the Health Act 2007. Existing legislation on cancer prevention is collected in the Public Health Act of 2018. On the other hand, eHealth applications in cancer care are not regulated by any specific law. In this case, general legislation is usually applied.
ITALY
In Italy, the use of telemedicine is detailed in Law 24 of 2017, so called ‘Gelli Bianco Law’. Legislation on cancer prevention is regulated by the Law of 29 March 2019. On the other hand, the country does not provide further information on specific legislation on eHealth applications in cancer care. In this case, general legislation is usually applied.
LITHUANIA
Lithuania has no specific legislation on telemedicine, cancer prevention or eHealth applications in cancer care. Note that where no specific legislation is in place, commonly, general legislation is applied. Extraordinarily, Lithuanian law mentions telemedicine in an Order for the provision of emergency telemedicine services, No. 2020-17220 (11/08/2020).
LUXEMBOURG
Luxembourg has implemented legislation on the use of telemedicine (Law of 28 July 2017). The Grand-Ducal Regulation of 18 August 2011 addresses the collection, storage and use of health data, including information related to cancer care. The country does not provide further information about specific legislation on cancer prevention, in this case general legislation is usually applied.
LATVIA
The Medical Treatment Law of Latvia sets the framework for the use of telemedicine. The country has no specific legislation on cancer prevention or eHealth applications in cancer care. In the first case, the Regulation of Cabinet of Ministers No. 555 (28/08/2018) determine measures of state-organised cancer screening. On the other hand, eHealth applications in cancer care are generally addressed by the Regulation of the Cabinet of Ministers No. 134 (11/03/2014).
MALTA
Malta has no specific legislation on telemedicine or eHealth applications in cancer care, instead the provisions of the EU General Data Protection Regulation and the Data Protection Act (Chapter 586 of the Laws of Malta) regulates this service. The country does not provide further information about specific legislation for cancer prevention nor for eHealth applications in cancer care. Usually, when there is no specific legislation in place, general legislation is applied.
NETHERLANDS
Implementation of telemedicine in the Netherlands is included in several regulations (Electronic Data Exchange in Healthcare and Medical Treatment Contracts Acts). On the other hand, the Public Healthcare Act indirectly addresses cancer prevention. The country has no specific legislation on eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation.
NORWAY
There is legislation on telemedicine (Health Register and Patient Records Act) and cancer prevention (Health Research and Personal Data Acts, Cancer Register regulations) in place included in the ‘ordinary’ health legislation. The country has no specific legislation on eHealth applications in cancer care, in which case general legislation is usually applied in the absence of specific legislation.
POLAND
Poland has no specific legislation on telemedicine, since this term does not count with a statutory definition. Instead, it is mentioned in the Act on Medical Activity (Art. 3 sec.1-2a of the Act of 15 April 2011). Some other acts also mentioned telemedicine or concepts related, such as Act of 5 December 1996 on the Professions of Physicians and Dentists, the Act of 15 of July 2011, on the Profession of Nurses and Midwifes or the Ministry of Health Regulation of 12 of August 2020, among others. Cancer prevention or eHealth applications in cancer care are not regulated by specific legislation either, whereas general legislation is applied.
PORTUGAL
The use of telemedicine in Portugal is regulated by several orders (3571/2013, 8445/2014, 6280/2018) and resolutions (293/2021, 67/2016). The country has introduced several laws for cancer prevention as well: Law 37/2007, Decree-Laws No. 173/2008, 178/2003, 85/2005, etc. Law 53/2017, of July 14 creates and regulates the National Cancer Registry, that includes eHealth applications in cancer care.
ROMANIA
Implementation of telemedicine in Romania is detailed in the resolution 1133 14/09/2022, as part of Health Law (Chapter V,30^1), and cancer prevention is regulated in the Law 293 (03/11/2022). The country has no specific legislation on eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation.
SWEDEN
The regulatory aspect of using telemedicine is related to the following legislative framework: Patient Data Act (SFS 2008: 355) and Regulation (SFS 2008:360), the National Board of Health and Welfare’s regulations concerning patient records and processing of personal data within healthcare (HSLF-FS 2016:40) and the management system for systematic quality of work (SOSFS 2011:9). The country has no specific legislation on cancer prevention or eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation.
SLOVENIA
Telemedicine is regulated generally in line with the regulations for the provision of health services in the state by the Slovenian Health Services Act, articles 1(3) and 3(3). The country has no specific legislation on cancer prevention or eHealth applications in cancer care, only an Act on Health Care and Health Insurance. General legislation is usually applied in the absence of specific legislation.
SLOVAK REPUBLIC
Law 153/2013 Coll. on the national health information system, which is currently under amendment, details the use of telemedicine in the Slovak Republic. On the other hand, the Law for cancer prevention is the No. 577/2004 Coll. (Annex 2). The country has no specific legislation on eHealth applications in cancer care, but general legislation is usually applied in the absence of specific legislation.
OUR X
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cc: @ecan_ja