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The legal aspects of MAST:

The legal aspects of MAST: potential challenges and opportunities I sabelle ANDOULSI Lawyer

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The legal aspects of MAST:

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

  2. The Legal Aspects of MAST: potential challenges and opportunitiesIntroduction • An assessment in two steps • Legal aspects included in the MAST • Other relevant legal aspects • How can information be collected on legal aspects? • Practical experiences • Questions MAST Seminar, 5th May 2010, Berlin MAST Seminar, 5th May 2010, Berlin

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

  4. The Legal Aspects of MAST: potential challenges and opportunitiesLegal 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, 5th May 2010, Berlin

  5. The Legal Aspects of MAST: potential challenges and opportunitiesLegal 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, 5th May 2010, Berlin

  6. The Legal Aspects of MAST: potential challenges and opportunitiesClinician 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, 5th May 2010, Berlin

  7. The Legal Aspects of MAST: potential challenges and opportunitiesProfessional 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, 5th May 2010, Berlin

  8. The Legal Aspects of MAST: potential challenges and opportunitiesInformation 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, 5th May 2010, Berlin

  9. The Legal Aspects of MAST: potential challenges and opportunitiesPatients’ 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, 5th May 2010, Berlin

  10. The Legal Aspects of MAST: potential challenges and opportunitiesOther 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, 5th May 2010, Berlin

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

  12. The Legal Aspects of MAST: potential challenges and opportunitiesPractical 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, 5th May 2010, Berlin

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

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

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