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Towards a European legal framework for data protection ...
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Roland KRAUSE, Krister HELBING, Johannes DREPPER, Sebastian Claudius SEMLER TMF Office – Berlin, Technology, Methods, and Infrastructure for Networked Medical Research, Berlin, Germany – [email protected] Towards a European legal framework for data protection – Implications for scientific research of the draft EU Data Protection Regulation Synergy, quality & standards – shared solutions for health Key changes of the EU Data Protection Regulation Proposal 2012/0011 (COD) : • A right to be forgotten (not about erasing past events) • Easier access to your own data • When consent is required you must be asked to give it explicitly • More transparency about how your data is handled – easy to understand • Being informed about data losses • Increased responsibility and accountability • Exemptions for research – Art. 83 Processing of personal data concerning health which is necessary for historical, statistical or scientific research • Definition of health data: purposes of preventive or occupational medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, reasons of public interest in the area of public health, other reasons of public interest in areas such as social protection purposes, such as patient registries Medical science research-networks in Germany being members of the TMF TMF book & publication series (more at www.tmf-ev.de/Produkte/Uebersicht.aspx) TMF working groups (WG) • WG Biobanking • WG IT infrastructure and quality management • WG Data protection, privacy and security • WG Management of clinical trials • WG Medical technology • WG Molecular medicine • WG Zoonosis and infection research • WG Forum grid • WG Patients representatives forum develop: - expert & legal opinions - consulting - eServices - IT infrastructure & tools etc. available for free! Infobox TMF (more : www.tmf-ev.de) TMF - Technology, Methods, and Infrastructure for Networked Medical Research e. V. - is an umbrella organization for medical research networks in Germany. As of October 2011, 89 mostly academic medical research networks and institutes across the country are members of TMF. The TMF was founded as a non-profit organizaton in 1999 and is funded by the Ministries of Education and Research (BMBF), of Health (BMG), of Economics and Technology (BMWi), and the the German Research Council (DFG). The TMF aims at improving the organization and infrastructure for networked medical research, i.e. clinical, epidemiological and translational research. Main Expertise at TMF • Legal and ethical framework conditions • Quality management & controlling • Interconnection of research and health care • Standards and terminology • IT infrastructure for clinical research Informed consent Biospecimen quality Biobanking regulations Data protection Philosophy at TMF • Bottom-up approaches & consensus-driven • Address scientist-defined needs • Develop generic solutions BACKGROUND - SUMMARY Accurate data is vital to enlightened research and policymaking, particularly publicly available data that are redacted to protect the identity of individuals. Privacy is vital when it comes to health and biomedical research. Until now our health records have been pretty well protected, mostly by inefficiency. With electronic medical records and the widely shared health data that Utopia requires we can’t put our trust in inefficiency any longer. The implementation of a 1995 directive of the European Union (95/46/EC), has created a scattered array of differing national legislations within Europe. Some countries even have different regional laws on data protection, making it even harder for cross-border data transfer for research. A first proposal for Data Protection Regulation was published by the EU Commission in January 2012. Ensuring data protection across Europe Patient Clinical Host Data- Warehouse EHR4CR Host EHR4CR Internal EHR4CR Interface Research Unit Data User Consents Consultation, tests, scans, etc. Dictionaries, Standards, etc. Extracts Criteria Contact Request Sign-in Request formulation Grant credentials User Register Contact Details Candidate Collation Candidates Approvals Access Log Initiate Study (A) (B) Approach (A) Clinician Vetting Clinician Contacts Study Consent Candidate Details Study Info Approach (B) Vetted Contact Details Researcher Contacts • Would need initial response of number of possible candidates, plus follow-up status of approaches, consents and rejections
Transcript of Towards a European legal framework for data protection ...
Roland KRAUSE, Krister HELBING, Johannes DREPPER, Sebastian Claudius SEMLERTMF Office – Berlin, Technology, Methods, and Infrastructure for Networked Medical Research, Berlin, Germany – [email protected]
Towards a European legal framework for data protection –Implications for scientific research of the draft EU Data Protection Regulation
Synergy, quality & standards – shared solutions for health
Key changes of the EU Data Protection Regulation Proposal2012/0011 (COD) :
• A right to be forgotten (not about erasing past events)
• Easier access to your own data
• When consent is required you must be asked to give it explicitly
• More transparency about how your data is handled – easy to understand
• Being informed about data losses
• Increased responsibility and accountability
• Exemptions for research – Art. 83 Processing of personal data concerning health which is necessary for historical, statistical or scientific research
• Definition of health data:
purposes of preventive or occupational medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, reasons of public interest in the area of public health, other reasons of public interest in areas such as social protection purposes, such as patient registries
Medical science research-networks in Germany being members of the TMF
TMF book & publication series(more at www.tmf-ev.de/Produkte/Uebersicht.aspx)
TMF working groups (WG)• WG Biobanking• WG IT infrastructure and quality management • WG Data protection, privacy and security• WG Management of clinical trials• WG Medical technology• WG Molecular medicine• WG Zoonosis and infection research• WG Forum grid• WG Patients representatives forumdevelop:- expert & legal opinions - consulting -eServices - IT infrastructure & tools etc.
available for free!
Infobox TMF (more : www.tmf-ev.de)
TMF - Technology, Methods, and Infrastructure for Networked Medical Research e. V. - is an umbrella organization for medical research networks in Germany. As of October 2011, 89mostly academic medical research networks and institutes across the country are members of TMF. The TMF was founded as a non-profit organizaton in 1999 and is funded by theMinistries of Education and Research (BMBF), of Health (BMG), of Economics and Technology (BMWi), and the the German Research Council (DFG). The TMF aims at improving theorganization and infrastructure for networked medical research, i.e. clinical, epidemiological and translational research.
Main Expertise at TMF• Legal and ethical framework conditions• Quality management & controlling• Interconnection of research and health care• Standards and terminology• IT infrastructure for clinical research
Informed consent
Biospecimen quality
Biobanking regulationsData protection
Philosophy at TMF• Bottom-up approaches & consensus-driven• Address scientist-defined needs • Develop generic solutions
BACKGROUND - SUMMARY
Accurate data is vital to enlightened research and policymaking, particularly publicly available data that are redacted toprotect the identity of individuals. Privacy is vital when it comes to health and biomedical research. Until now our healthrecords have been pretty well protected, mostly by inefficiency. With electronic medical records and the widely shared healthdata that Utopia requires we can’t put our trust in inefficiency any longer. The implementation of a 1995 directive of theEuropean Union (95/46/EC), has created a scattered array of differing national legislations within Europe. Some countrieseven have different regional laws on data protection, making it even harder for cross-border data transfer for research. A firstproposal for Data Protection Regulation was published by the EU Commission in January 2012.
Ensuring data protection across EuropePatient Clinical
Host Data-Warehouse
EHR4CR Host
EHR4CR Internal
EHR4CR Interface
Research Unit Data User
Consents
Consultation, tests, scans, etc.
Dictionaries, Standards, etc.
Extracts
CriteriaContactRequest
Sign-in
Requestformulation
Grantcredentials
User Register
ContactDetails
CandidateCollation
Candidates
Approvals
Access Log
InitiateStudy
(A) (B)Approach (A)
ClinicianVetting
ClinicianContacts
Study Consent
CandidateDetails
Study Info
Approach(B)
VettedContactDetails
ResearcherContacts
• Would need initial response of number of possible candidates, plus follow-up status of approaches, consents and rejections
