How To Understand The Rules Of The European Union

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1 Telehealth and the Law: An Update from Both Sides of the Atlantic John Williams, MD Associate Medical Director, University of Pittsburgh Medical Center International and Commercial Services Division (Moderator) Cynthia O Donoghue Partner, Reed Smith LLP (London, UK) Terrence Lewis Associate Counsel, University of Pittsburgh Medical Center

2 INTERNATIONAL LAWS, TREATIES, AND ACTS On December 17, 2010, U.S. Department of Health and Human Services signed a Memorandum of Understanding with the European Commission in which both parties agreed to cooperate on topics directly pertaining to the use and advancement of ehealth/health IT in pursuit of improved health and health care delivery as well as economic growth and innovation. 2

3 Current State of Telemedicine Law Advances in medicine and medical technology related to telemedicine remain far ahead of the legal precedents and standards for this area of healthcare law. 3

4 E.U. and U.S. Telehealth Legal Issues: Physician Licensure and Credentialing Patient Privacy and Medical Records Professional Liability (Medical Malpractice) Reimbursement 4

5 PHYSICIAN LICENSURE/CREDENTIALING International aspects Currently, NO international or EU license to practice telemedicine. Currently NO standard credentialing process. Various Model Acts by interested organizations: World Medical Association International Bar Association draft International Convention on Telemedicine and TeleHealth 5

6 European Union - Competencies in the area of Telemedicine Member States have prime responsibility for organisation and delivery of healthcare - Art. 168(7) Treaty on the Functioning of the EU (TFEU) Areas where EU level action is needed relate to cross-border issues and free movement in the internal market Art 114 TFEU EU subsidiarity principle (which requires decisions be made at the most decentralised level) - Art 5(3) TEU Character of telemedicine Covers issues relating to the EU internal market, health policy, information communications & telecoms, R&D, data protection, consumer rights, employment and social policy 6

7 EU & Telemedicine Telemedicine is the provision of a service E-Commerce Directive 2000/31/EC applies to Information Society Services between Member States and bars derogations relating to protection of public health Information Society Service = Any service normally provided for remuneration, at a distance, by means of electronic equipment for the processing (including digital compression) and storage of data and at the individual request of a recipient of a service Professional Qualification Recognition Directive 2005/36/EC not applicable requires physical presence of the health professional in the patient s country 7

8 Telemedicine Issues Telemedicine can improve access to specialised care in areas suffering from a shortage of expertise, or in areas where access to healthcare is difficult. Use of telemedicine is still limited and the market highly fragmented. Although Member States have expressed their commitment to wider deployment of telemedicine, most initiatives are no more than one-off, small-scale projects that are not integrated into healthcare systems. Member States health authorities have primary responsibility for organisation, financing and delivery of healthcare and it is up to them to make telemedicine a reality in the life of European patients stems from principle of subsidiarity

9 New Directive on Cross-Border Healthcare Directive 24/11/EU of 9 March 2011 Aims to facilitate access to healthcare by promoting cooperation on healthcare between EU Member States Definition: Member State of treatment means the Member State on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established Article 7(7): The Member State of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare, including healthcare received through means of telemedicine, the same conditions, criteria of eligibility and regulatory and administrative formalities, whether set at a local, regional or national level, as it would impose if this healthcare were provided in its territory. This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient s entitlement to healthcare. However, no conditions, criteria of eligibility and regulatory and administrative formalities imposed according to this paragraph may be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless it is objectively justified by planning requirements relating to the object of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. Requires compliance with EU Data Protection Directive

10 PATIENT PRIVACY European Union Data Protection Directive 95/46/EC special rules apply to: "the processing of personal data concerning health or sex life" (Art 8(1) Sensitive data can only be processed when it is necessary to protect the vital interests of the individual usually interpreted to mean the provision of healthcare. Sensitive personal data may not be transferred outside the European Union unless: transferred to an adequate protection jurisdiction transferred pursuant to the EU Standard Contractual Clauses Individual s freely given and explicit consent has been obtained transfer is necessary to protection the vital interests of the individual All Privacy Principles apply 10

11 PATIENT PRIVACY European Union Privacy Principles Data must be: Processed lawfully (vital interests/contract) and lawfully Collected only for a specified, explicit and legitimate purpose Adequate, relevant and not excessive for purpose(s) collected Accurate and current Kept secure Kept only as long as is necessary for purpose(s) collected No transfers of data outside the EEA to third countries without adequate laws to protect personal data

12 PATIENT PRIVACY European Union EU Data Protection Directive (continued) Rights of Individuals: Patients have a right to request a copy of any personal information held about them i.e. medical records. Ability to revoke consent to transfer at any time without adverse affect or penalty Right to correction Controllers processing personal data must notify data protection supervisory authority, unless otherwise exempt. In some but not all EU Member States provision of healthcare is exempt. 12

13 PATIENT PRIVACY European Union Draft Proposed General Data Protection Regulation due 2014/2015 Article 4 definition of data concerning health means any information which relates to the physical or mental health of an individual, or to the provision of health services to the individual; Article 81 obliges Member States, further to the conditions for special categories of data, to ensure specific safeguards for processing for health purposes. Explanatory notes: The processing of personal data concerning health deserves higher protection [and] may often be justified by a number of legitimate reasons for the benefit of individuals and society as a whole, in particular in the context of ensuring continuity of cross-border healthcare. Therefore this Regulation should provide for harmonised conditions for the processing of personal data concerning health 13

14 REIMBURSEMENT European Union Cross-border level EU Directive on patients rights in cross-border healthcare states that as a general rule, patients will be allowed to be reimbursed up to the level of costs that would have been assumed by the member state of affiliation. No EU case-law on reimbursement of telemedicine services yet National level National legislation of Member States governing reimbursement according to their health systems In some Member States, telemedicine is not recognised as a proper medical act for reimbursement purposes 14

15 LIABILITY for telemedicine services European Union Medical liability and services liability - no EU legislation - National legislation of the individual Member States applies - Applicable national law to be determined (Regulation on applicable law to contractual obligations + Regulation on applicable law to noncontractual obligations), but new Directive deems care to be provided at location of primary care giver is that whose law will be deemed to apply and under what circumstances - Competent court to be determined EU consumer protection legislation (e.g. No fault liability for defective products) No liability of intermediaries (e.g. Internet service providers) for mere conduit, caching or hosting (e-commerce Directive) 15

16 U.S. Definitions of Telemedicine and Telehealth CMS (for new credentialing final rule): telemedicine encompasses the overall delivery of healthcare to the patient through the practice of patient assessment, diagnosis, treatment, consultation, transfer and interpretation of medical data, and patient education all via a telemedicine link (e.g., audio, video and data communications) and which is not restricted to only patients in rural areas of the nation. CMS (for Medicare billable services in rural areas): telehealth services include a two-way, real-time interactive communication between the patient and a physician at a distant site, but do not include communications via telephone, , or fax. 42 U.S.C. Sec. 1395(m)(m)(1); 42 CFR Sec (a)(3). 16

17 PHYSICIAN LICENSURE United States The U.S. Supreme Court has held that states have a compelling interest in the practice of professions within their boundaries, and that as part of their power to protect the public health, safety, and other valid interests, they have broad power to establish standards for licensing practitioners and regulating the practice or professions. 50 different states = 50 different state boards of medicine that regulate the practice of medicine. Currently, no national license to practice medicine. 17

18 PHYSICIAN LICENSURE United States In the vast majority of U.S. states, the practice of telemedicine likely requires a full, unrestricted license (with certain exceptions) if the physician s activities meet the specific state s definition of practicing medicine. Special Telehealth License Exceptions: approximately fifteen (15) U.S. states have laws that permit a specific telemedicine license. Other Exceptions: in certain states if care is provided on an infrequent/emergency basis or if the physician is providing consultative services on a provider-to-provider basis and the on-site physician retains full authority over all care decisions. 18

19 PHYSICIAN CREDENTIALING United States New Final CMS Rule (Effective July 5, 2011): allows the medical staff of the hospital where the patient is being treated via telemedicine to rely upon the credentialing and privileging done at the hospital located where the telemedicine practitioner is credentialed. Effect: Streamlined credentialing now available which reduces start-up time for new telemedicine activities. 19

20 PATIENT PRIVACY AND MEDICAL RECORDS United States Health Insurance Portability and Accountability Act (1996) (federal law applies to all 50 states) HIPAA Privacy Rule (2000) HITECH Act (2009) Practice Point: Remember, individual states may have stricter privacy laws than what is required by HIPAA. 20

21 REIMBURSEMENT United States Conditions for Medicare reimbursement of telemedicine services: Patient located in rural/remote areas Live, real-time situations Second physician physical present with patient (telepresenter) Appropriate state licensure Practice Point: Reimbursement from the U.S. government for telehealth services is limited (patient must be located in a rural and remote area). 21

22 REIMBURSEMENT United States Local Laws Expanding Approximately 12 states have enacted laws that allow physicians to be reimbursed for telemedicine. For example, in Pennsylvania all citizens enrolled in the State s Medical Assistance plan are covered for reimbursement purposes regardless of the patient s location. 22

23 RECOMMENDATIONS If telemedicine is to expand more broadly, stakeholders will need to take the lead in providing regulations with recommended standards and processes that assure appropriate use of public funds. Creation of standardized national and international telemedicine licenses. Creation of a standardized national and international credentialing processes and policy for accepting third party credentialing. Creation of uniform national and international regulations for medical record and patient health information use and storage to ensure protection of patient privacy. Development of broader models for telemedicine service reimbursement by the U.S. and EU. 23

24 QUESTIONS? 24