The legal aspects of MAST:

The legal aspects of MAST:

potential challenges and opportunities

IIsabelle ANDOULSIsabelle ANDOULSI

LawyerLawyer Researcher at the ULBResearcher at the ULB

[email protected]@d-lawfirm.be

MAST Seminar, 5MAST Seminar, 5thth May 2010, Berlin May 2010, Berlin

The Legal Aspects of MAST: potential challenges and opportunitiesThe Legal Aspects of MAST: potential challenges and opportunities

IntroductionIntroduction

I. An assessment in two stepsII. Legal aspects included in the MASTIII. Other relevant legal aspects IV. How can information be collected on legal aspects?V. Practical experiencesVI. Questions




Legal Assessment OverviewLegal Assessment Overview

A Legal Assessment in two (2) steps:

Assessment of the existing legal framework

Assessment of particular legal obligations



Legal Assessment : Step 1Legal 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....



Legal Assessment : Step 2Legal 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.



Clinician AccreditationClinician 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?



Professional LiabilityProfessional 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)?



Information GovernanceInformation 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



Patients’ RightsPatients’ 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



Other Relevant Legal AspectsOther 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



Collection of Information on Legal AspectsCollection of Information on Legal Aspects

Laws and regulations

Studies (doctrine)

Case Law

Referral to judicial and ethics committees



Practical Experiences with Description of Legal Practical Experiences with Description of Legal AspectsAspects

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.



Thank you for your attention



Questions time…..


Documents

The legal aspects of MAST: