1. Telemedicine in Norway: Responsibility issues and legislation concerning access to EHR Ellen K. Christiansen, senior legal adviser Norwegian Centre for Telemedicine Ellen.Christiansen@telemed.no

2. What is telemedicine? It is the investigation, monitoring and management of patients and the education of patients and staff using systems which allow ready access to expert advice and patient information no matter where the patient or relevant information is located.” (Advanced Informatics in Medicine 1991)

3. Circular I-12/2000: Telemedicine and responsibility Applies to: Telemedicine used for consultation and diagnostics Does not apply to: Telemedicine used for educational and administrative purposes

4. The typical situation: Specialist in hospital Patient and health staff elsewhere Video camera

5. Circular I-12/2000: Telemedicine and responsibility It is possible to deliver health care in the legal sense of the term without F2F- contact between doctor and patient The allocation of responsibility does not change when telemedicine is used All health professionals have to make sure that delivering health care via telemedicine is in accordance with best practice in each case

6. Act of 2nd July 1999, no 64 relating to health personnel etc. (The Health personnel Act), section 4: (In English: http://www.ub.uio.no/ujur/ulov/ “Ord i tittel: health personnel”)http://www.ub.uio.no/ujur/ulov/ Responsible conduct Health personnel shall conduct their work in accordance with the requirements to professional responsibility and diligent care that can be expected based on their qualifications, the nature of their work and the situation in general.

7. In other words: It is up to the health staff to make sure that they have the adequate information about the patient to initiate an appropriate treatment If not, they must fetch more information, perhaps see the patient F2F

8. Conclusions from the circular Use of telemedicine does not alter the liability conditions The general health legislation applies to telemedicine services For an assessment to be appropriate, it must be based on relevant and necessary information When telemedicine tools are used, the underlying assumptions should be made clear in advance The providers have to establish quality assurance systems for the use of telemedicine

9. Any problems? Reimbursement issues Documentation in practice Communication of patient information Not exactly problems, but issues to focus on: –Clarification of responsibility –Clarification of underlying assumptions

10. Information flow in health care - simplified ©Ellen K. Christiansen, NST

11. Communicating patient information: Queries to be asked Access to EHR-systems-who decides? Do you need consent from the patient to process their health information electronically?

12. A (very) controversial legal provision in Norway: Act on personal health data filing systems and the processing of personal health data [Personal Health Data Filing System Act], section 13: (In English: http://www.ub.uio.no/ujur/ulov/) Ord i tittel: “personal health”)http://www.ub.uio.no/ujur/ulov/

13. About: Access to personal health data in the data controller’s and the data processor’s institution Only the data controller, the data processors and persons working under the instructions of the controller or the processor may be granted access to personal health data. Access may only be granted insofar as this is necessary for the work of the person concerned and in accordance with the rules that apply regarding the duty of secrecy.

14. The four Norwegian Regional Health Authorities: Mid NorwayWestern N Northern N South- Eastern N ETC. 8 Health Trusts7 Health Trusts6 Health Trusts 16(?)Health Trusts ©Ellen K. Christiansen, NST

15. On the one hand: ”Just in case” “We can offer better treatment” “The patients do not care” It makes life easier for health staff “We can save more lives” “Why can’t we do it in the health care sector, when the banks can handle it?” © : Chris Slane

16. On the other hand: The need for information? –In what situations? –What kind of information? –The consequences? When damage is done.... Do the patients care? Data security and professional secrecy The European Convention on Human rights, Article 8