Telemedicine and legal aspects Brussels, 2 March 2010

1. Telemedicineand legal aspects Brussels, 2 March 2010 Prof. dr. Peter Pattynama, radiologist Erasmus university Rotterdam (NL) p.m.t.pattynama@erasmusmc.nl UEMS e-Health working group

2. Teleradiology case Professional teleconsulting • Tele-radiology • - nuclear medicine • - dermatology • - pathology

3. From point-to-point connection

4. To e-market place

5. Teleradiology case • Licensing professional standards, patient safety teleradiology = medical act ? • Reimbursement business model ? appropriate pricing of teleradiology service incentive for 2nd expert reading? • Liability legal clarity and certainty

6. Standard situation • Current situation, national levels • 3-parties involved • Regulation by national government

7. Add teleradiology

8. Possible contractual relations Direct contract between teleradiologist and local: Radiologist Common arrangement; subcontracting Hospital Common whenever local radiologist is hospital employee. Hospital administrations greatly interested (cost containment) Trust Common arrangement in United Kingdom Insurer ? GP ? Patient Not common, but entirely possible through diagnostic center In all cases other than subcontracting: False competition between local radiologist (by law required to be a specialist doctor) and teleradiologist (not required to be a specialist doctor or even MD) [communication] Dutch patient loses the extra opportunity to sue the local radiologist: loss of legal security In case of direct contract between teleradiologist and patient Protection according directive on e-Commerce? Loss of legal security?

9. Conflict situations In conflict situations the question is: • Who has a contractual relation with whom • How are these relations governed by law For cross-border conflicts (international civil law) • Which judge is qualified (jurisdiction) • Which law applies (which can be different from that of qualified judge) • Can a verdict be materialized in a specific country

10. Our concerns • Medical Services are imported from a distant site, that can be cross-border within the European Union (European Economic Area) cross-border outside of the European Union • We want to maintain safety and quality standards for healthcare • We want to maintain legal certainty for patients and health professionals • What happens in case of conflicts or medical mistakes? • Complex legal issues, containing elements of European law, national health law, national civil law, international civil law, consumer law (all consistent?) • Telemedicine providers are not necessarily doctors/health professionals, because Telemedicine is not officially considered a medical act • Telemedicine providers have less access to relevant clinical data

11. Legal framework (work in progress..) Health care is heavily regulated field at member state level Different in 27 member states In addition: many European directives and court rulings already apply: Consumer protection: E-Commerce directive Data protection Dir. 95/46/CE, protection of individuals, processing of personal data Dir. 2002/58/EC, protection of privacy in electronic communications European Court of Human Rights (I vs Finland, 17 July 2008!) COM(2008)414. Proposal for Directive on … cross-border healthcare

13. Our view on the proposed directive • The use of telemedicine should adhere to the same professional medical quality and safety standards as standard (non-electronic) health care This contains, by definition, the requirement to use all available clinical data also in telemedicine • Doctors undertaking cross border telemedicine … should have the equivalent regulatory requirement to those of the country where the patient accesses healthcare • Regulation of telemedicine … should be the responsibility of the member state where the patient undergoes the … medical treatment. • Patients must be provided with comprehensive information regarding the outsourcing of image interpretation and give informed consent. • Specific telemedicine services should be classified as medical acts

14. Reimbursement issues What is appropriate price for teleradiology product = radiology report Historically: “radiology report” is our end-of-the-line product But radiology service also entails clinical services that actually occupy most of our working time Now that “radiology report” can be outsourced What does this mean for reimbursement of our “clinical services” 2nd Expert readings undoubtedly improve quality of care Are insurers willing to pay for such extra reading ?

15. Reimbursement issues • Patient-related radiologists’ working time Estimate: Film interpretation and reporting: 30% of time expenditure Other patient-related activities: 70% • Conferencing in multidisciplinary teams • Organizing workflow in department • Consultancy • Justification of examination in individual patient • Optimizing, tailoring individual examination • Ad-hoc problem solving whenever they arrive: proximity / accountability /responsibility • Optimizing fast, efficient diagnostic work-up for patient • Diagnostic impact, therapeutic impact • Quality control

16. Summary • Teleradiology can play positive role in cost containment and quality improvement • Directive on Cross-border Healthcare ? The well-drafted proposal has eased many of our professional concerns regarding legal issues and liability The proposal in its present form seems politically contentious • Reimbursement issues remain to be addressed

17. Specific national situations Example The Netherlands • 1st Analysis done 2007 for the Dutch Society of Radiology by Prof. emiritus Harold Sanders Law professor/radiologist, Former Dean of Maastricht University • 2nd Analysis done 2008 in collaboration with Prof. Siewert Lindenbergh Professor of civil law, Erasmus university, Rotterdam Academic Board Pan European Organisation of Personal Injury Lawyers • Master thesis project of two of his graduate students Dans E, van der Vorst PR. Teleradiology: Some legal implications of a new phenomenon [Dutch]. Tijdschr voor Gezondheidsrecht 2008; 32:187-199 • Analyses apply to only The Netherlands • For a European overview: 26 more analyses required

18. Specific Dutch law rules (1) Radiology examinations are highly regulated and subject to • professions in individual healthcare law Wet BIG (1993) • professional conduct of healthcare professionals law Tuchtrechtbesluit BIG • agreement to medical treatment law WGBO (1994) • Quality law on healthcare institutions Kwaliteit Zorginstellingen • Decision on radiation protection Besluit stralenbescherming • Privacy protection of personal data Wet bescherming persoonsgegevens 2000 – • A person who performs radiological examinations with machines that employ ionizing radiation needs to be able and licensed, i.e., has to be trained as a radiologist and be on the Dutch register of medical specialists/radiology • The interpretation is an integral part of the radiological examination

19. Specific Dutch law rules (2) Requirement to provide complete information. Always. • The hospital has the duty to inform the patient he has a choice between Telemedicine and regular care AND • has to inform the patient about the issues that he should reasonably know to make such a decision AND • The hospital has to offer the alternative option Problem The patient may expect to be “treated” by a certified and capable medical specialist. But this is not necessarily the case: Telemedicine is not a medical act. “Or we will have a local medical specialist look at your examinations, or we will send it out to an outside commercial firm (who need not be doctors and who do not have all your medical information), and for you this second option has no specific advantages”

20. Specific Dutch law rules (3) • The radiologist has to interpret the diagnostic examinations having learned all relevant information, including clinical data • The referring doctor and the radiologist should be able to communicate about the findings on the diagnostic examinations But how much information is relevant? (need for professional guidelines) Should the teleradiologist be available for telephone conferencing? Is it ok if communication is done by the local radiologist as a “go-between”?