1. The legal aspects of MAST: potential challenges and opportunities Isabelle ANDOULSI Isabelle ANDOULSI Lawyer Lawyer Researcher at the ULB Researcher at the ULB ia@d-lawfirm.be ia@d-lawfirm.be MAST Seminar, 5 th May 2010, Berlin

2. The Legal Aspects of MAST: potential challenges and opportunities Introduction I.An assessment in two steps II.Legal aspects included in the MAST III.Other relevant legal aspects IV.How can information be collected on legal aspects? V.Practical experiences VI.Questions MAST Seminar, 5 th May 2010, Berlin

3. The Legal Aspects of MAST: potential challenges and opportunities Legal Assessment Overview A Legal Assessment in two (2) steps: Assessment of the existing legal framework Assessment of particular legal obligations MAST Seminar, 5 th May 2010, Berlin

4. The Legal Aspects of MAST: potential challenges and opportunities Legal Assessment : Step 1 Is the implementation of telemedicine in accordance with: Legislation regulating medical care provision; Accreditation systems for care providers; Liability for care provision; Other relevant legislations.... MAST Seminar, 5 th May 2010, Berlin

5. The Legal Aspects of MAST: potential challenges and opportunities Legal Assessment : Step 2 As regards the second level of assessment, the following issues have to be taken into consideration: Clinical accreditation; Professional liability; Information governance; Patients’ rights. MAST Seminar, 5 th May 2010, Berlin

6. The Legal Aspects of MAST: potential challenges and opportunities Clinician Accreditation Questions to be answered: Are clinicians accredited to deliver services at distance? Is their accreditation valid at their registration location? Is their accreditation valid at the point of delivery? MAST Seminar, 5 th May 2010, Berlin

7. The Legal Aspects of MAST: potential challenges and opportunities Professional Liability Questions to be answered: Does the accreditation regulation of each actor of the system envisage liability problems? Who is responsible for what in the system (think about every event)? MAST Seminar, 5 th May 2010, Berlin

8. The Legal Aspects of MAST: potential challenges and opportunities Information Governance Issues linked to patient identifiable information access and transfers are: Data processing Access rights of clinicians Responsibilities of data controllers and processors Free flows of personal (medical) data within the telemedicine application MAST Seminar, 5 th May 2010, Berlin

9. The Legal Aspects of MAST: potential challenges and opportunities Patients’ Rights The rights of the patients are: Right to be informed Right to access their data Right to rectify their data Right to object the processing MAST Seminar, 5 th May 2010, Berlin

10. The Legal Aspects of MAST: potential challenges and opportunities Other Relevant Legal Aspects Confidentiality and Security High standards, appropriate to the data type Liability Service supply Integrity of the data Medical devices regulations Intellectual property rights Data ownership Re-use of clinical data MAST Seminar, 5 th May 2010, Berlin

11. The Legal Aspects of MAST: potential challenges and opportunities Collection of Information on Legal Aspects Laws and regulations Studies (doctrine) Case Law Referral to judicial and ethics committees MAST Seminar, 5 th May 2010, Berlin

12. The Legal Aspects of MAST: potential challenges and opportunities Practical Experiences with Description of Legal Aspects From the practical experiences she had describing the legal aspects of several telemedicine applications for different actors, the professional recommends you: Not to fear the laws and regulations; To define the concepts used in a particular application; To bear in mind legal aspects can be very different in each application; To envisage your application in the broadest way possible. MAST Seminar, 5 th May 2010, Berlin

13. The Legal Aspects of MAST: potential challenges and opportunities Thank you for your attention MAST Seminar, 5 th May 2010, Berlin

14. The Legal Aspects of MAST: potential challenges and opportunities Questions time….. MAST Seminar, 5 th May 2010, Berlin