Domain 7: Socio-cultural, ethical and legal aspects: Legal Aspects. Petra Wilson Continua Health Alliance. Treviso, 9 February 2012

Transcription

1 Domain 7: Socio-cultural, ethical and legal aspects: Legal Aspects Petra Wilson Continua Health Alliance Treviso, 9 February 2012

2 Social, Ethical and Legal Issues Three common core elements: Autonomy Ø dignity and free will of the patients Ø informed consent Justice Ø equitable availability Ø Beneficence/nonmaleficence Ø benefits patients and does no harm. 9 February

3 Step 1: Legal Analysis Identify Applicable legislation - list all legislation which had to be addressed e.g. data protection, professional accreditation, responsibility issues, professional conduct / best practise, patients rights, etc. - note which EU level legislation such national legislation was based upon. Note Special steps taken to fit application to legislative requirements any modification to applications or intended uses which were abandoned in order to comply with legislation 13 April

4 Step 2 : Wider Legal Issues Describe the other legal issues which had to be addressed and how that was done the main areas to be discussed should include: 1. Clinician and device accreditation 2. Information governance 3. Professional liability 4. Patient control and responsibility 9 February

5 Clinician accreditation Did existing professional accreditations cover the requirements of the application? Were the professionals able to complete all the necessary tasks under their existing accreditations? How was professional liability for engagement in the trial addressed and insured? Was liability shared between different professional actors? Was there any element of patient liability in the trial? 9 February

6 System or device accreditation/certification Were the systems or devices used in the application subject to rules of certification (e.g. Medical Device Directive CE certification)? If yes, were all devices or systems intended for use in the application certified or did substitutions have to be made? 13 April

7 Information Governance (1) How was consent to data collection obtained (written, oral, proxy)? How were patients clearly informed about what data were to be collected, who would have access to the data, and for purposes? How were patients given access to data collected? 9 February

8 Information Governance (2) How were patients able to correct or delete data collect about them in the trial? Who had access to data and for what proposes How was access to data controlled (password, ID, ) With whom were data shared? Were any patient consent override measure used?. If so, why and how were they controlled (e.g. sealed envelopes )? 13 April

9 Information Governance (3) How were data stored, what security measures were implemented? What measures were taken to ensure integrity/non repudiation of transferred/ shared data? What measures were taken to ensure accessibility of data by all appropriate parties? 29 February

10 Professional liability Were existing liability insurance mechanisms sufficient for the application? Did any new insurance or other mechanisms have to be adopted? How was liability between different actors balanced? 13 April

11 Patient control / responsibility Ethical / legal issue Human rights - access to services Patients rights - access and control Creating balance between responsibilities of parties Shared liabilities Relevant education and support 13 April

12 Legal Issue Legislation Applicability/ amendment Clinician accreditation Eg Professional Registra0on Creating and completing the Legal Analysis Table Needed new rules for remote clinican ID management Device certification Information Governance Professional liability Patient responsibility Eg Medical Devices Law Medical Devices Direc0ve Eg Data Protec0on Law Data Protec0on Direc0ve Pa0ent Dossier law Eg Medical profssional insurance law 12

13 Creating and completing the Wider Legal Issues Table Issue Clinician accreditation Device certification How issue was addressed New system of clinican ID was established Dates May 2012 Evidence Reqired close co- opera0on with local ethics and professional regista0on ceee Information Governance Professional liability Patient responsibility 13

14 Agnes Story Agnes is a 60 year old woman living in a remote area of the island of Funen in South Denmark, visited her GP (Dr Birger) complaining of pronounced general fatigue and swelling in her legs, ankles and feet. Dr B s examination revealed an abnormally high blood pressure and a mild arrhythmia. Based on these findings Dr Birger referred Agnes to the cardiology unit at Odense University Hospital where a series of examinations revealed a congestive heart failure due to a faulty heart valve. Based on her diagnosis and the fact that she lives far away from Odense the hospital doctors recommend that Agnes enrolls in the Cardiology Telemedicine Programme run in conjunction with a specialist cardiology centre in Edinburgh. As a patient of that programme Agnes is provided with an implanted cardiac monitoring device.

15 Agnes Story The device logs the heart s rhythm; the flow of blood through the heart, as well as the effort expended by the heart and will automatically upload the readings to a web-based interface which Agnes, Dr Birger and the cardiologists of the Cardiology Telemedicine Programme can access. The web tool will send an automatic alert to the treating physician if the values are out of normal range. In the event of a significant abnormality in recorded results the device itself will emit a signal prompting A to call a cardiology nurse who will establish if she needs immediate assistance using a decision support tool linked to the device. If immediate support is needed a web based video conferencing session is arranged and Alison will see one of the specialists based in Odense or Edinburgh via video conference from her GP s practice. If necessary an ultrasound examination will be done in the GP practice and transmitted live to the cardiologists.

16 Issues in Agnes Story Ø An implanted monitoring device Ø Automa0c aler0ng Ø Decision support Ø Remote second opinion All of them raise ques0ons about responsibility for data flow, advice and ac0ons

17 Data from device Data Protection and Privacy

18 Data Protection - the doctors and hospitals duties Doctor must: Ø Ensure consent is informed, specific and freely given. Ø Ensure patient knows who has access to what data and for what purpose. Ø ensure that nominative data is treated securely Ø Ensure that technical data is treated securely or anonymised Ø Enure that specific consent is obtained for any research

19 Secondary use of data? Ø Could the data from the data fromt he PHR be used for research purposes? Ø What levle of control should the pa0ent have? Ø Do the public health benefits outweight privacy considerab0ons?

20 Data Protection and Privacy - EU Legislation Directive 95/46 on Data Protection Ø Objective: to facilitate internal market through free movement of data, through harmonized rules, within a framework of respect for privacy and personal life (ECHR art 8) Ø Provide special protection for sensitive data, including medical data (art 8) o informed consent o for medical treatment o by a healthcare professional (note now General Data Protection Regulation) Directive 2002/58 Electronic Communications Security of networks and services Confidentiality of communications

21 Medical Devices An implanted medical device SoOware for data collec0on and sharing

22 Medical Devices - the doctors and hospitals duties Provider s must: Ø Ensure that it is used within manufacturer s guidelines Ø Ensure that any sooware used with it is duly accredited as a part of the device or as an accessory Ø Ensure the pa0ent understands how to use the device - possible contributory liability of pa0ent

23 Medical Devices EU Legislation Dir 90/385/EEC Ac;ve implantable Medical Devices, amended by 2007/47/EC Ø Must be safe Ø Must be accredited with CE mark Ø Must be supplied with and used in accordance manufacturer s instruc0ons Ø Manufacturer must foresee all reasonable uses with Ø Includes any sooware intended by its manufacturer to be used specifically for diagnos0c and/or therapeu0c purposes Ø Generally manufacturer will be strictly liable for harm arising from product

24 Remote Physician Alert Video based consulta0on Telemedicine Services

25 Telemedicine Service Providers Duties Service provider must: Ø Obtain informed consent of pa0ent Ø Ensure pa0ent understands country of origin principle if applicable Ø Ensure secure storage, processing and transmission Ø Ensure medical staff are fully briefed Ø Ensure adequate insurance

26 Providers Duties - EU Legislation Directive 2000/31 on Information Society Services and Electronic Commerce Applies to some medical services Country of origin principle applies For regulated professions - detail of local accreditation, and local applicable rules Special rules on contract formation right to rescind Telecoms service provider is a mere conduit, not liable for the information transmitted

27 Patients Right EU Legislation Pa;ents Rights in Cross- Border Care - Direc&ve 2011/24/EU (to be implemented by 25th Oct 2013) Art 12 Reference networks Art 13 Rare diseases Art 14 ehealth Interoperability, eprescrip0on Access to care not available, or not available in reasonable 0me frame Reimbursed in accordnace with local rules

28 An ethical challenge in A s case: Removing or deactivating an implanted medical devices Ø Questions: Are doctors legally entitled to turn off devices? Are doctors legally obliged to turn off devices? Who should turn off devices? Does a DNR notice apply?

29 Telemedicine - Public Trust is Key

30 Thanks Petra Wilson,