implementation of cross-border eprescription services · 2015-03-09 · • hl7 v3: cda r2 level 3...

Implementation of cross-border ePrescription services

Päivi Hämäläinen, THL, Finland

14 May 2014

2014 eHealth Forum, Athens

28.1.2014Päivi Hämäläinen, THL, 2014 eHealth Forum, Athens, 14 May 2014 2

Other National Services

National KanTa Services

ePresciption

Dispensations

eArchieve

Patient RecordsManagement Servce

Descriptive Data

Patient Summary Service

Consent & Will ManagementService

Opt-In / Opt-out

OrganDonation Wills

Living Wills

National Code Server

Code Lists, Terms

Document Structures

Pat

ien

te

Acc

ess

Pharmacies (816)

Hospital Districts (21)

Health Centres (192)

Private Healthcare Providers (>4000)

Citizens (> 5 600 000)

Diagnoses

Lababoratory

Imaging

Operations

Vaccines

Measurements

Registry of Healthcare Professionals

Certification Services

ep

SO

SN

CP

EU Member States / epSOS NCP

Medication Database

Risks Medication Health Treatment Plan

Main Standards• HL7 V3: CDA R2 Level 3

and Medical Records• IHE IT-I Profiiles• W3C XML-Signature• WS Addressing, WS-I• TLS, X.509 Organisation Registry

Information

Imaging

IHE

IHE

X

DS

-I

Registry of Pharmacies

Prescriptions

Renewal Requests Log Files

Log Files

HL7

V3

WS

Me

dic

alR

eco

rds

Inte

rfac

es

Source: [email protected] 3

http://www.kela.fi/in/internet/suomi.nsf/

http://www.kela.fi/in/internet/suomi.nsf/

mailto:[email protected]

ePrescriptions in Finland

• ePrescription has been in production since May 2010.

• Fully rolled out in pharmacies and public health care, roll-out ongoing in private health care.

Päivi Hämäläinen, THL, 2014 eHealth Forum, Athens, 14 May 2014 4

Joining the eP service is

obligatory today and eP will be

the only choice after 2017

• 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).

epSOS Pilot - Finland


eP (Country A) Dec 2013

eD (Country B) March 2014

• The roles and responsibilitiesin national and cross-borderservices defined by law;

• THL (National Institute for Health and Welfare) responsible for operationalmanagement and implementation

• Kela (Social Insurance Institution of Finland) responsible for technicaldeployment including the NCP.

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

• 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.

Challenges due to the integration of the service

into national infrastructure and production


Lot´s of practical issues!

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.


• 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 thecross-border exchange of e-prescription data in EU.

Amendments to existing law needed


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 http://www.kanta.fi/en/omakanta


http://www.kanta.fi/en/omakanta

http://www.kanta.fi/en/omakanta

There it is – the first ever true e-prescription dispensed abroad in Europe; now there are 10…


All challenges could be overcome, so…


And as soon as you

log in to your Finnish

”MyKanta” , you

can see the info

on your medication

dispended abroad

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


• 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)


The path towards the nationwide deploymentof the cross boarder eP

implementation of cross-border eprescription services · 2015-03-09 · • hl7 v3: cda r2 level 3...

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