Implementation of cross-border eprescription services. Päivi Hämäläinen, THL, Finland 14 May ehealth Forum, Athens

Transcription

1 Implementation of cross-border eprescription services Päivi Hämäläinen, THL, Finland 14 May ehealth Forum, Athens

2 Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

3 IHE epsos NCP IHE XDS-I HL7 V3 WS Medical Records Interfaces Patient eaccess National KanTa Services Citizens (> ) epresciption Renewal Requests Prescriptions Log Files Dispensations Pharmacies (816) Hospital Districts (21) Health Centres (192) Private Healthcare Providers (>4000) earchieve Descriptive Data Patient Summary Service Diagnoses Operations Imaging Vaccines Lababoratory Log Files Patient Records Management Servce Imaging Measurements Risks Medication Health Treatment Plan EU Member States / epsos NCP Consent & Will Management Service Organ Donation Wills Living Wills Information Opt-In / Opt-out Main Standards HL7 V3: CDA R2 Level 3 and Medical Records IHE IT-I Profiiles W3C XML-Signature WS Addressing, WS-I Other National Services National Code Server Code Lists, Terms Document Structures TLS, X.509 Organisation Registry Registry of Pharmacies Registry of Healthcare Professionals Certification Services Medication Database Source: Konstantin.Hypponen@kela.fi 3

4 eprescriptions in Finland eprescription has been in production since May Fully rolled out in pharmacies and public health care, roll-out ongoing in private health care. Joining the ep service is obligatory today and ep will be the only choice after 2017 Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

5 epsos Pilot - Finland ep (Country A) Dec 2013 ed (Country B) March 2014 epsos e-prescription service was regarded as: a natural extension of the Nordic exchange of (paper) prescriptions in operation since 1970s a natural add-on to the national electronic prescription services Finland will have no paper choice for prescription, a need for an electronic solution to the requirements laid down by the Implementation Directive 2012/52/EU Real-life pilot (in operational environment) with Sweden Country A coverage is national, Country B limited to a border region in Northern Finland consisting of three municipalities and their pharmacies (a border region). Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

6 epsos Pilot Architecture From the onset focus was on creating a sustainable integrated service - running the pilot had to be integrated with an existing national ep The roles and responsibilities in national and cross-border services defined by law; THL (National Institute for Health and Welfare) responsible for operational management and implementation Kela (Social Insurance Institution of Finland) responsible for technical deployment including the NCP. Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

7 Challenges due to the integration of the service into national infrastructure and production Legal: not possible to go live without revision of existing national legislation Organisational: Localisation of the legal framework of epsos more than a matter of mere translation; responsibilities according to national law differ from those set out in FWA > national law has to be followed. Intense collaboration with other competent authorities was required and consensus on many solutions had to be found. Technical: Within the project timeframe not possible to integrate epsos fully into national infrastructure > the chosen pilot portal solution may not be the sustainable one. The creation and integration of the cross-border consent management into existing national system is a sustainable solution. Semantic: Challenges due to the shortcomings of ATC and in mapping of some code sets (e.g. EDQM, UCUM) and due to unstructured data > certain types of prescriptions and drugs were ruled out and some epsos prescriptions might be incomplete. Lot s of practical issues! Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

8 Legal issues almost became a show-stopper The cross-border exchange of personal health data between countries within EU is based on the data protection directive (Directive 95/46/EC). This directive and related national laws work as the legal base for cross-border exchange of data also in the epsos context. In Finland special regulations on the processing of personal data in other laws and acts; e.g. the handling of electronic prescription data is governed by a special law, the Act on Electronic Prescriptions. The Act originating from 2007 and revised in 2011 had been drafted from a national perspective did not recognize the cross-border scenario, the law had to be amended in order to allow for dispensation of eprescriptions that do not fully comply with the Finnish requirements. Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

9 Amendments to existing law needed As the Act on electronic prescriptions in Finland did not recognize the cross-border scenario, the law had to be amended in order to allow for dispensation of eprescriptions that do not fully comply with the Finnish requirements. Lengthy process and dependent on other legislative reforms. Revised regulation was issued in March 2014 after two years. The law now contains an article ( 23a) laying down the cross-border exchange of e-prescription data in EU. Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

10 Integrated consent management system The cross-border exchange of prescription data requires an informed and explicit consent given by the patient in the country of affiliation and a transfer of this consent to the NCP. Finland decided to include the epsos consent into the national consent management system in order to prepare for a sustainable solution. The citizens online service is accessible on Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

11 All challenges could be overcome, so There it is the first ever true e- prescription dispensed abroad in Europe; now there are 10 Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

12 And as soon as you log in to your Finnish MyKanta, you can see the info on your medication dispended abroad Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

13 The Finnish experience - lessons to be shared A real live operation is possible, however only after a systematic implementation of all technical, legal and organizational requirements National investment in addition to project allocations is a prerequisite National structures and bodies, and a certain level of maturity of the national ehealth systems are a prerequisite Compliance with commonly agreed frameworks, guidelines etc. is a necessity. A single MS must be able to trust other MSs. National laws take precedence over joint agreements or specifications, therefore the cross-border service scenario should be envisaged in all national regulatory work in advance. Common issues still to be solved on European level: digital signature, substitution rules, standard to represent multiple active ingredients in medications, rules for the reimbursement of eps Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May

14 The path towards the nationwide deployment of the cross boarder ep Continued operation of ep and ed services with Sweden, potentially other countries is envisaged. The post pilot deployment as a service business as usual requires: Documented political commitment on national level (we have the law, this helps) budget allocations Capacity to maintain the services (incl. terminologies/codes, NCP functionalities etc.) Infrastructure and adjunct services such as consent management on national level Willingness of the pharmacies to offer the service, i.e. to take the epsos web into use (in log term fully integrate to national ep) Päivi Hämäläinen, THL, 2014 ehealth Forum, Athens, 14 May