*Funded by the European Commission
GDPR Compliance and The International Patient Summary An IPS Workshop Brussels, 13 th September 2018
GDPR Compliance and The International Patient Summary Introduction and Welcome Stephen Kay Vice Chair of CEN/TC 251 CEN IPS Project Team Leader
The Shared Vision “In order to further the care for citizens across the globe, collaborate on a single, common International Patient Summary (IPS) specification that is readily usable by all clinicians for the (cross-border) unscheduled care of a patient.” November, 2016. OSLO 6
Management of expectations… • Why are you here? • What do you want to achieve? • Write a sentence or two… • Share? • Evaluate what you have got from this workshop… 7 TC 251 The International Patient Summary
Objectives of this IPS workshop • To understand what GDPR Compliance means for the International Patient Summary (IPS), its Implementation, – both now and in the future, – in Europe and beyond. • To inform extended forms of Patient Summary • To make specific recommendations, to ensure the best possible implementation guidance for IPS (TS 17288) in Europe
International Patient Summary (IPS) Workshop, Agenda 1. Introduction and Welcome - Stephen Kay, CEN IPS Project Team Leader 2. Some Context (10-minute presentations) a. GDPR: Present State - Matthias Pocs, Convenor of CEN/TC251-WG1 b. Status of the IPS standards - Giorgio Cangioli, HL7 International c. HL7 GDPR on FHIR - Alexander Mense, HL7 (Austria) d. Sharing clinical documents - Stéphane Spahni, HUG & IHE-Europe co-chair e. H2020 SHiELD overview - Ed Conley, AIMES >> LUNCH 12:00-13:00 << 3. Workshop practical, facilitated group discussion, and review of outputs : o The IPS Use Case and IPS scenarios o the application of the SHiELD method Use cases to support GDPR Compliance
Stakeholder Influences TC 251 The International Patient Summary 10
Stakeholder Awareness TC 251 The International Patient Summary 11
Complexity if not Chaos • Multiple things going on simultaneously – Some may be divisive; some may be duplicative; some complementary; – Each with their own motivation, pressure, timings – Some totally unaware of what others are doing – Multiple endeavours in different implementations – multiple horizon scans and even current landscapes… – Ignorance is bliss…but not for the real consumer…oblivious and oblivion 12 TC 251 The International Patient Summary
Impossible? Patient Summary • National initiatives • Different starting points • Changing landscape • Consider multiple EC projects in parallel • Deployments • Change in policies • General exchange formats • Terminology wars • … • Joint Initiative Council (JIC) • CEN and HL7 • GDPR… • Research and service needs… PH34.. H2020.. 13 TC 251 The International Patient Summary
A Quote from <<…>> “I don’t envy you… Its like trying to change a tyre on a speeding vehicle!” 14 TC 251 The International Patient Summary
International Patient Summary 15 TC 251 The International Patient Summary
https://www.youtube.com/watch?v=KPJXSGbfNkI
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Context Sessions GDPR: Present State - Matthias Pocs Status of the IPS standards - Giorgio Cangioli HL7 GDPR on FHIR - Alexander Mense Sharing clinical documents - Stéphane Spahni H2020 SHiELD overview - Ed Conley 18 TC 251 The International Patient Summary 3/16/2017
ReEIF Arrow # Stakeholders Meaning Governance 1 SDO Design and Maintenance 2 SDO, Citizen Provenance, fairness, transparency Data Protection (DP); Privacy and 3 Implementers, Assess risks, accountability, Data Security Healthcare providers Protection by Design and by Default Legal and X-border health data, DP harmonisation 4 Government, Regulators Regulatory and Enforcement 5 Policy makers Selection, formalisation and sharing Policy 6 SDO Clinical and Citizen drivers; Trustworthy Care Process 7 Healthcare providers Use, validation 8 SDO, Implementers Models and terminologies Information 9 SDO, Implementers Models and exchange formats 10 Implementers Implementation considerations Applications - - - Infrastructure N/A 11 SDO Feedback and sustainability Standards, Profiles, 12 Citizens, Validation and Value and Evaluation Healthcare-providers
1 1 Implementors Governance ReEIF SDOs SDOs Considerations Implementors Governments 2 3 Data Protection; Policy-makers Privacy and Security 4 4 Legal and Regulatory 5 IPS Dataset Specification Policy IPS Creation and and 6 7 IPS Value Sets IPS Exchange Care Process (Product view) (Process view) 8 9 Information 10 Applications Infrastructure N/A Healthcare- Healthcare-Providers 11 Standards, Profiles, 12 Providers Citizens and Evaluation Citizens Regulators Regulators
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IPS Scenario Commentary (1) • An explicit, initial requirement for developing the IPS was to enable citizens of one country to receive relevant treatment for their unplanned health need in another country. • Soft- box 1 (SB1) stars ‘adult’, ‘ health need ’ and ‘foreign country’ for the reader’s attention. First, ‘adult’ is highlighted because the starting dataset assumes that the ‘ subject of care ’ in question is an adult staying in a foreign country either for business or leisure; if the citizen is a child, it maybe that additional data might be required in a patient summary (for example, legal guardian details and the person’s date of birth are already in the eHN dataset but data such as Apgar scores are not). 23 TC 251 The International Patient Summary
IPS Scenario Commentary (2) • Second, the ‘ health need ’ is, as yet, unspecified; it may or may not relate to a chronic health condition , but the eHN dataset, the starting requirement for this standard, is intended to be “minimal and non- exhaustive” implying that the data elements are valid as a core set applicable to any health condition, perhaps with the expectation that other data could be added as required. • The fact that it is a ‘health need’ should not prevent a summary from expressing social, mental and spiritual conditions (the 1948 WHO definition of health is very inclusive); that having been said, the data elements comprising the current IPS dataset major on the healthcare aspects of well-being and would have to be substantively extended and revised to provide adequate coverage for the core parts of a more inclusive summary. 24 TC 251 The International Patient Summary
IPS Scenario Commentary (3) • Third, ‘foreign country’ is starred, because although ‘cross - border’ was the impetus for establishing the eHN dataset, the experience of the epSOS project showed that the value of the patient summary is much greater at a national and local level. • Indeed, a cross-border application is probably non-viable without the buy-in of more localised benefits (see “Attitudes towards the impact of digitisation and automation on daily life”, Eurobarometer 460, May 2017). • The cross-border concept then is best considered as a specialised case, perhaps a more difficult one, of cross-boundary problems, which include jurisdictional as well as professional and organisational boundaries. The IPS must deliver value to national and local healthcare parties as well as regional and international ones. 25 TC 251 The International Patient Summary
IPS Scenario Commentary (4) • Soft- box 2 (SB2) ‘ demand for care ’ is specialized by ‘ demand for initial contact ’ (not shown), which results in a ‘ contac t’ (SB3) that is ‘unplanned’ (SB4). The eHN Guidelines indicates that this particular circumstance shows the most value/benefit for having the patient summary available at the point of care . • Soft-box 4 (SB4) an unexpected health need, does not limit the contact to an emergency. Indeed, emergency care is a specialty in its own right, often with its own dataset requirements, and the time-frame and context of an emergency may actually negate realistic access to the IPS unless it is held by the patient or their legal guardian and is directly available at the point of care. Note too that the IPS dataset is intended to be useful for ‘planned contacts’ too, albeit that the ‘unplanned care’ is the emphasis of the eHN Guideline. ‘Scheduled’ and ‘Unscheduled’ types of care are often used in the eHN Guidelines as synonyms for ‘planned’ and ‘unplanned’ care respectively. The 2 nd revision of the eHN Guidelines uses the term ‘unscheduled’, rather than • ‘unplanned’, which has more of an organisational connotation. Even so, it is the unexpected and urgent nature of the health need event that finds the healthcare provider unprepared, often with no prior record of the person to be treated. 26 TC 251 The International Patient Summary
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