5 General requirements for cross-border use of patient registries

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Methodological guidelines » 5 General requirements for cross-border use of patient registries

Content
5.1 Political context
5.2 Organisational aspects – Registries’ operations and procedures
5.3 Legal and ethical aspects
5.4 Semantic aspects
5.5 Technical aspects – Guaranteeing shareable data
5.6 Effective and sustainable solutions for cross-border registry collaboration
5.7 Health Data Resources in Europe: Mapping national strategies


Key messages:

  • In the PARENT JA vision, the cross-border use of registries is predicated on a continuous IT-assisted chain of health data capture, storage, processing, transmission and utilization.
  • Fulfilling the prerequisites for cross-border operations essentially means achieving interoperability in the broadest understanding of the term, i.e. on legal, organizational, semantic and technical levels as well as the establishment of effective, sustainable solutions for cross-border registry collaboration.
  • Policy context: Creation, maintenance and development of registries, as well as preparedness for cross-border operations is largely dependent on the positioning of health data resources in national strategic prioritization for scientific data resources and research infrastructures. Equally important is the question of whether registries are perceived as part of regional and/or national eHealth infrastructure.
  • Organisational aspects: Transparent procedures for granting access to or sharing data in a cross-border context must be in place, preferably including predefined response time targets.
  • Legal and ethical aspects: a patient registry can be established using either of two legal instruments; by explicit consent of the data subject, or based on law. Adoption of a consent model presumes thorough planning of the purposes of the registry and consultation with local data protection authorities or ethical committees.
  • Semantic aspects: comparability and transferability of health data across languages and contexts of use is heavily dependent on the adoption and use of accepted coding standards.
  • Technical aspects: crucial in ensuring that health data are shareable; hence adopted solutions must support or be compatible with regional/national infrastructures and semantic requirements for patient data collected in the process of healthcare services provision.


Cross-border use of registries can take several different forms as the mapping work of PARENT has demonstrated, among others registry networks (e.g. the International Association of Cancer Registries, the Nordic Arthroplasty Register Association NARA), international clinical studies (e.g. GRACE – Global Registry of Acute Coronary Events) and international registries (e.g. IBIR - International Breast Implant Registry). There are several strong drivers in using registry data across borders, such as the needs for studying differences between countries in morbidity, effectiveness of health system-level interventions and utility of procedures; the advantages of large international datasets vs. national ones in the timely detection of rare, or previously unknown effects; gathering and promoting information on best practices worldwide.

Independent of the motive driving the utilization of cross-border registries, the success of the endeavour will always rely on the degree of achievement of certain prerequisites, the implementation of which starts at a local level - regional and/or national. PARENT Joint Action aims at the idea of establishing a continuous IT-assisted chain of health data capture, storage, processing, transmission and utilization. Therefore the purpose of fulfilling these prerequisites is the achievement of interoperability in the broadest understanding of the term, i.e. on legal, organizational, semantic and technical levels (see chapter 3) as well as the establishment of effective, sustainable solutions for cross-border registry collaboration. The focus of this chapter is primarily on the requirements imposed by legal and organizational interoperability aspects, and to a lesser extent on semantic and technical interoperability issues; these are in turn addressed in more detail in chapters 3 and 10. An exception is the topic of metadata, which we briefly discuss here. A more detailed analysis of organizational interoperability aspects with regard to stakeholders and their roles constitutes part of the business models analysis of PARENT (D6.2. – forthcoming), while policy aspects and necessary actions are discussed in the respective deliverable (D6.1. – forthcoming). It should be kept in mind that the allocation of requirements to respective interoperability aspects is at least to some extent artificial. Several requirements span many if not all levels of interoperability, even if they are discussed under a predominant heading.

5.1 Political context

The creation, maintenance and development of registries, as well as their preparedness for cross-border operations is largely dependent on the positioning (or lack thereof) of health data resources in national strategic prioritization regarding scientific data resources and research infrastructures. PARENT has analysed in a parallel activity national strategies and initiatives concerning Health Data Strategies and the ways in which they impact patient registry work. A brief sample of the findings is provided in Table 5.1.

Equally important is the question of whether registries are perceived as part of a regional and/or national eHealth infrastructure. At EU level, Member State collaboration in the field of eHealth has until now focused primarily on the creation and exchange of health data at the point of and for the purposes of patient care, as reflected in the work of the eHealth Network on ePrescription and Patient Summary [1][2]. The needs and requirements of secondary use of data, where the formation and utilization of registries also belong, have until recently remained unexplored. However, in order to achieve the vision of electronic collection, processing and re-use of health data throughout its lifecycle while ensuring the fulfilment of interoperability requirements, e-enabled registries need to be included as a target of national eHealth agendas, thereby establishing the link with ongoing EHR initiatives in Member States.

5.2 Organisational aspects – Registries’ operations and procedures

Researchers’ access to classified registry data has generally been quite complicated and time consuming starting with locating appropriate data, preparing research applications and on to requesting permissions and negotiating data transmissions or access rights. Each one of the steps in this process can take a variable length of time and incur widely differing costs, depending on the registry holding the data in question. Both elements though may turn into considerable barriers, particularly from the perspective of socially and politically urgent research or regulatory work. New solutions for more straightforward application processes and remote access to data are being developed.

Procedures for granting access to or sharing data in a cross-border context must be in place, preferably including predefined response time targets. An organizational culture oriented towards data sharing, as well as appreciation of data utilization beyond own organizational remits, combined with appropriate resourcing are essential elements in achieving a high level of preparedness. Collaboration with other registries’ holders is advisable, in order to exchange experiences, advice and ideas.

Open data is an overarching idea which stretches to cover parts of classified data in the form of metadata. Openly publishing the content information of limited access systems would boost the efficiency of scientific research, enhance the quality of results, increase transparency and help create new research ideas.

5.3 Legal and ethical aspects

Utilizing patient registry data is an asset for science and the patient and health care sector. However, the right to privacy and data protection are fundamental rights (European Charter of Fundamental Rights) [3]. Therefore, securing the privacy of the patients or research subjects is an essential task when establishing and maintaining a patient registry or when conducting registry-based research. Moreover, when processing personal data, the data controller has to take into account not only legal, but also ethical perspectives.

The most important European law affecting patient registries’ operations is the Data Protection Directive (95/46/EC) [4] that regulates the collection, processing and distribution of personal data. Registry holders should always be aware of the basic notions and effective norms of Data Protection. Currently the implementations and interpretations of the Data Protection Directive vary between Member States. Similarly the roles of Data Protection Authorities and Ethical Committees differ greatly. The legislative process toward the new harmonizing Data Protection Framework is still ongoing. At the same time, the European Union Directives and Regulations considering Medical Devices, Pharmacovigilance, Clinical Trials and Cross-Border Health Care induce new information needs that will increase demand for patient registry data. Registry holders should actively follow the ongoing overhauls of the aforementioned laws.

By and large a patient registry can be established using either of two legal instruments; by explicit consent of the data subject, or based on law. Current practices among the EU Member States registry holders’ surveyed by PARENT appear to be almost equally divided between the two models. The final content of the forthcoming Data Protection Regulation will play a decisive role in the choices available for registry establishment and operations in the future.

The adoption of a consent model assumes a thorough planning of the purposes of the registry. The required content of informed consent varies between Member States. For this reason it is important to consult local Data Protection Authorities or ethical committees in the process of formulating the consent model. The Opinion of the European Data Protection Working Party (WP 29) regarding the definition of consent (WP 29, 2011) [5] provides a thorough analysis of the concept as currently used in the Data Protection Directive.

According to the existing Data protection Directive Article 2.h “the data subject’s consent” means any freely given, specific and informed indication of his/her wishes by which the data subject signifies his/her agreement to personal data relating to him/her being processed. The definition of the Directive implies an opt-in strategy of the consent. For the legal protection of the registry holder and patient, it is advisable that the consent is given in written form. If personal data are transferred abroad, this should be communicated in the context of acquiring informed consent.

As noted earlier, by and large a patient registry can be established either by the explicit consent of the data subject, or based on law. The explicit consent, where the data subject approves the processing of his/her personal data, is the primary instrument (if indeed it is possible to ask the consent of the data subject), since the protection of one’s privacy is the fundamental right of the data subject. However, there are no right answers to when it is possible to ask for the subject’s consent and when not. When it comes to small, disease-specific registries, in principle the consent of the data subject is the legal instrument for establishing and maintaining the registry. For example, this might be the case in rare diseases registries. If the data subject has a doctor-patient relationship with the representative of the data controller, what circumstances would justify not asking the consent of the data subject?
The ethical considerations of establishing a registry are far more complicated, if it is uncertain whether or not the data subjects are capable of giving informed consent. However, these situations are case-specific and require in-depth ethical evaluation. Registry holders should contact the respective local Ethical Committee concerning the ethical issues of registry establishment.
When the establishment of the patient registry is based on law, one should presume that the ethical grounds for doing so are reasonable. The registry holder has to maintain the privacy of the data subjects and ensure that operations abide by the data protection regulation (of course this has to be the case even when establishing the registry using the instrument of an explicit consent). Establishing and maintaining a patient registry based on law may be relevant for administrative, statistical, research and some other purposes. For example, in Nordic countries large population-based patient registries were established by law without the consent of the data subjects mainly for statistical and scientific purposes. However, the processing of this registry data is strictly regulated and the data can be utilized only for specific purposes. When the registry is established by law one has to assume that the benefits of establishing the patient registry are greater than following the principal rule of asking patients’ consents for registration. Using patient registry data for research purposes may prevent the unnecessary collection and processing of personal data.

Even though the European Commission has proposed a Regulation as a substitute for the existing Directive [6], it is also likely that some national legal variation regarding patient registries will continue to exist. These disparities reflect differences in Member States’ national health care systems, information infrastructures and legislations. It should not be assumed that legal and ethical interpretations and practices are identical across Europe. Thus, it is always advisable to consult regional or national Data Protection Authorities or ethical committees when establishing a registry. Recognizing the need for more streamlined processes, cross-border models of operations have also been considered especially regarding ethical committees (Nordic Trial Alliance; Nordforsk) [7]. One of the considered models is to develop procedures for mutual recognition of ethical approvals, in which approval in one country would be valid in the other countries, too in cases of cross-border research co-operation. However, these are still aims for the future and do not reflect the current situation. Securing privacy of the research subjects is a fundamental task when establishing and maintaining a patient registry. It has become a generalized interpretation that even encrypted and pseudonymous data are personal data. That is why it is pivotal to understand the basic notions regarding personal data in order to understand the areas where Data Protection rules are applicable. Registry holders and data processors should always be able to differentiate clearly the notions of pseudonymous data, encrypted data, anonymised data and aggregated data.

According to the Data Protection Directive, personal data means any information relating to an identified or identifiable natural person (“data subject”). An identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity.

The current Data Protection Directive does not define the often used concepts of pseudonymous data or encrypted data. One way to define pseudonymous data (According to the European Parliament’s proposal given in March 2014), is that it means personal data that cannot be attributed to a specific data subject without the use of additional information, as long as such additional information is kept separately and subject to technical and organizational measures to ensure non-attribution. Encrypted data then means personal data, which through technological protection measures are rendered unintelligible to any person who is not authorized to access it (European Parliament 2014). [8]

It is notable that according to these definitions both pseudonymous data and encrypted data are considered to be personal data. Therefore the Data Protection Law applies to them.

Anonymised data means data in which all identifiers have been removed so that there is no reasonable possibility to link data back to individual persons to whom data relates and no code key exists to link the data to persons. Anonymised data are not personal data as the data have been altered so that the data subjects can no longer be identified. The possibility to re-identify data subjects must be considered on a case-by-case basis. For example, the deletion of names and personal identity numbers is often not sufficient to make data anonymous. Complete anonymity requires that the possibility for both direct and indirect identification is removed and that the code key is destroyed.

Aggregated data means statistical data on individuals that has been combined to show values without the possibility to identify individuals within the aggregated data set. One practice has been to share and hand over aggregated or anonymised data in order to eschew the data protection norms. Often however, that is not possible as the analysis requires sharing of individual level data whether it is in an encrypted or a pseudonymous form.

The Data Controller of the Patient Registry should always be defined unequivocally. Data Controller, according to the Data Protection Directive, means the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data. Where the purposes and means of processing are determined by national or Community laws or regulations, the controller or the specific nomination criteria may be designated by national or Community law.

Data Processor, according to the Data Protection Directive, means a natural or legal person, public authority, agency or any other body which processes personal data on behalf of the controller. Third party means any natural or legal person, public authority, agency or any other body other than the data subject, the controller, the processor and the persons who, under the direct authority of the controller or the processor, are authorized to process the data. The recipient means a natural or legal person, public authority, agency or any other body to whom data are disclosed, whether a third party or not.

It is likely that the upcoming European Data Protection Framework will require more transparency and accountability from patient registry holders. Generally it is advisable to be open about the registration purposes and give clear information to maintain public trust and credibility of patient registries. This involves ethical and well-structured informed consent practices, as well as maintaining clear and open descriptions of the registry and its metadata online.

5.4 Semantic aspects

Operating in an international environment or the readiness to do so requires that solutions regarding linguistic barriers have been thought of and implemented – both at the level of data and at the level of generic information necessary for data sharing (e.g. information on procedures for access to data, application forms etc.)
The comparability and transferability of health data across languages and contexts of use is heavily dependent on the adoption and use of accepted coding standards (see chapters 3.2.5 and 10.11.3).

Metadata is “structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use, or manage an information source”. It is meant to describe the phenomenon it concerns, and also document its changes over time. Good quality metadata are vital for data utilization. To make datasets comparable and useful for other users and between registries, metadata should be standardized according to validated and widely used classifications. Another aspect of standardization is recording metadata elements in the registry’s information model in a specified structure. That is, to make standardization as complete as possible, it must also cover data architecture and programming details. There are numerous standards in use, stemming from different traditions in e.g. statistics, informatics and commerce. The International Organization for Standardization (ISO) has published standards called ISO/IEC 11179 and also ISO15000-3 and ISO15000-4 for representing metadata for an organization in a metadata registry [9][10]. The Dublin Core metadata terms are a set of vocabulary terms which can be used to describe a wide variety of resources [11]. Each of its 15 elements can be further defined with other vocabularies (e.g. SKOS, FOAF, ADMS, DCAT, QB). The Data Documentation Initiative (DDI) aims to connect the two aforementioned approaches [12]. A specific set of metadata in greater detail can be described in a data model (e.g. RDF, Topic Maps) and further in its presentation format (e.g. HTML, XML). As conditions and requirements vary in patient registry environments, instead of recommending the use of one particular standard, PARENT recommends the use of widely known standards in semantics, data model and presentation formats, as well as ensuring the interoperability in close communication with other registries.
When establishing and maintaining a registry, it is pivotal to identify the relevant stakeholders and generate a co-operation structure within them. The key stakeholders from the registry holders’ perspective are usually health care professionals, patients, pharmaceutical and medical devices industry, ICT-suppliers, policy makers, researchers and other registries. If taken further, the opening of detailed metadata in standardized format would ease the registries’ multi-stakeholder cooperation as well, particularly in the cross-border setting. The first step in opening registry metadata could include basic information about the data, such as description, owner, information content, target group, update intervals, dependencies from other data etc. preferably on the basis of agreed standards. This kind of increased visibility and traceability of health data collections would benefit patient registries and lead to new ideas and innovations. Joining yellow-page type services like the PARENT Joint Action Registry of Registries (PARENT RoR), the AHRQ Registry of Patient Registries (RoPR) or other specialized “umbrella” registry is a concrete implementation step and opportunity for identifying further areas for targeting development efforts.

As open data has recently gained importance also on state administration level (e.g. the British government’s “opening up government” initiative and the Finnish Ministry of Finances’ “open data programme”), open data and the possibilities it may yield must be carefully considered in the patient registry environment. Firstly, a line must be drawn between the data which can be opened given the technical, and, above all, data security restrictions, and the data which cannot be opened (such as patient registries’ microdata).

5.5 Technical aspects – Guaranteeing shareable data

There are different levels of implementation for the technical solutions required, starting from the choices made at the level of an individual registry and up to the level of platforms for cross-border sharing of data. It is not the purpose of these guidelines to take a stand in advising for or against the use of specific technological solutions, since these are both context-specific and a constantly moving target as new technologies emerge. However, the technical layer is crucial in ensuring the ‘shareability’ of health data and hence adopted solutions must be such that take into account and support regional/national infrastructures and semantic requirements for patient data collected in the process of healthcare services provision.

On the level of technical operationalization of legal requirements, particularly in terms of data protection and safety, adopted solutions must be robust and reliably proven to perform the expected tasks.

5.6 Effective and sustainable solutions for cross-border registry collaboration

The creation of effective and sustainable solutions for cross-border use of registry data is a process where all the aforementioned requirements must be concertedly brought into play in order to serve clearly defined unique targets, such as those explored in the PARENT Joint Action Scenarios. The added value generated by achieving these targets will act as the key driver for the engagement of stakeholders who in turn can guarantee the sustainability of the required cross-border registry infrastructure and operation environment, a subject discussed in detail in the respective PARENT Joint Action report.

5.7 Health Data Resources in Europe: Mapping national strategies

The development of registries, as well as their preparedness for cross-border operations is largely dependent on the positioning of health data resources in national strategic prioritization regarding scientific data resources and research infrastructures.

One of the priorities of PARENT was to investigate, map and analyse the current policy and strategy landscape regarding the utilization of health data resources in EU Member States. The primary focus was on strategies concerning existing national databases and registries (possibly established mainly for administrative purposes) but also patient data generated in the process of health care service provision and delivery (e.g. the database of healthcare provider organizations), as well as newly-generated research data. The reason for embarking on this work was that the creation, maintenance and development of registries generally and particularly in the long run will depend considerably on the position the subject of health data resources has or has not acquired on national level strategic prioritization.

The challenges included the following:

  • not all countries have an established strategy on the subject (e.g. Member States with a long registry tradition, such as the Nordic countries clearly do, but that cannot be assumed for everyone)
  • the organizations/institutions responsible for the subject and hence authors of a possible strategy were quite diverse, hence a broad scope is needed in conducting the preliminary search
  • a significant body of work has been accomplished under broader subjects such as eScience and generally research oriented initiatives
  • the work needed to cover both the Member States, as well as the EU-level developments

The following table summarizes indicative countries with the main findings of the national strategies mapping.

Table 5.1 National strategies mapping[note 1]
STRATEGY LEAD ORGANISATION MAIN ACTORS KEY POINTS
Croatia
  • National Health Care Strategy 2012 - 2020
  • MoH
  • Croatian National Institute of Public Health
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Public health IT system
  • Central Health Care Information System in Croatia (CEZIH)
  • Direct retrieval of the patient’s data from the Electronic Health Record
  • Public health IT system manages more than 33 registries which are, however, neither linked nor standardized;
  • Drafting of the Strategy of integral management of health care archive and registry material in the Republic of Croatia for the period from 2012 to 2020 is in progress
  • Pharmacovigilance system development based on electronic adverse event reporting
Cyprus
  • “Digital Strategy for Cyprus” (2012)
  • MoH
  • Ministry of Communications and Works
  • Health Monitoring Unit
  • high quality and high speed electronic services, while ensuring the security of infrastructures and information
  • paperless government & eGovernment services
  • Integrated Health Care Information System in all hospitals;
  • Regional health networks, AAL, Telemedicine use
Denmark
  • Danish Roadmap for Research Infrastructures (2011)
  • National Action Plan for Strengthening Public-Private collaboration on clinical research (2014)
  • MAKING eHEALTH WORK - National Strategy for Digitalisation of the Danish Healthcare Sector (2013-2017)
  • Danish Agency for Science, Technology and Innovation
  • National Experimental Therapy Partnership (NEXT)
  • National eHealth authority
  • National Service Platform (NSP)
  • The Clinical Trials office Denmark
  • Statens Serum Institut
  • Danish National Biobank Coordinating Centre
  • Political focus on creating framework conditions conducive to research & business development in healthcare& welfare
Estonia
  • National Health Plan (2009 - 2020)
  • Ministry of Social Affairs
  • Other ministries (incl. Ministry of Economic Affairs & Communications, Ministry of Education and Research
  • local governments and civil organisations
  • HIAS – Health Information and Analysis System: monitoring system to collect data on the health status of different population groups, any possible changes and past interventions plus data management, preservation and initial analysis
  • Ensuring quality of the collected data and comparability of different data sources; Establishing links between different datasets
  • Child health, population sexual and reproductive health and infant health indicators and impact factors through surveys, development of medical registries and health information systems and specification of the content of collected data.
Ireland
  • Ireland eHealth Strategy (2013)
  • Department of Health
  • eHealth Ireland
  • Council of Clinical Information Officers
  • eHealth Ecosystem
  • eHealth as National Infrastructure Investment
  • Expected outcomes to be delivered in phase one – years 1- 4: High quality data sets are available to indicate public health trends and inform regional and national policy
  • Improved ability to support surveillance and management of public health interventions
  • Improved ability to analyse and report on population health outcomes
  • Benefits to Ireland: Public Health is greatly enhanced by the availability of high quality and accurate data sets which can be readily accessed and mined. Trends in population data can be observed and if necessary interventions can be enacted. Valuable longitudinal studies can be performed from anonymised data sets which can be used to inform national policy.
  • The Health Services Executive (HSE) has established the National ICT Integrated Services Framework (ISF). The ISF is an Interoperability Framework offering a shared standards based tool and language for defining and aligning the business and interoperability context for Ireland’s eHealth systems.
Norway
  • National strategy for health registries for the period 2010-2020
  • National Health Registry project (2011)
  • Health Registries for Research (2014)
  • Biobank Norway: A national infrastructure for Biobanks and Biobank related activity (2012)
  • Norwegian government
  • Ministry of Health and Care Services
  • Norwegian Research Council
  • National Institute of Public Health
  • Universities
  • BBMIR.no
  • co-ordinate and modernise the national clinical registries and the mandatory national health registries
  • Improve the use of data for research, health surveillance, prevention and quality assurance of healthcare.
United Kingdom
  • Health and Social Care Information Centre (2013
  • Department of Health
  • NHS England
  • Health and Social Care Information Centre
  • NHS has established Health and Social Care Information Centre with the aim of driving the use of information to improve decision making and deliver better care.
  • Secondary Uses Service (SUS) is the single, comprehensive repository for healthcare data in England which enables a range of reporting and analyses to support the NHS in the delivery of healthcare services.
  • Data Linkage and Extract Service provide extracts from a range of individual and linked data sets and can add significant value to individual sets of data by combining and matching them at individual record level in a secure environment.
  • Public Health Surveillance - Towards a Strategy for Public Health England (2012)
  • Public Health England
  • Public Health England
  • Public Health England Transition Team
  • Most commonly identified priority by stakeholders for strengthening the public health surveillance function was that greater use be made of existing data through linkage of those data and analyses of those linked data sets. Hold data securely in line with published information governance standards set out in the Department of Health’s Information Governance Toolkit.
  • Data and knowledge gateway (Beta site http://datagateway.phe.org.uk/?lk_sr=govphe) A single point of access to data and analysis tools from across Public Health England.
  • eHealth Strategy 2011 – 2017
  • The Scottish Government
  • NHS Scotland
  • eHealth Directorate
  • eHealth Strategy Board
  • Publication of an Information Assurance Strategy and core guidance including Records Management.
  • The UK Administrative Data Research Network: Improving Access for Research and Policy (2012)
  • Economic and Social Research Council / The Administrative Data Taskforce
  • Economic and Social Research Council
  • Medical Research Council and the Welcome Trust
  • An example of access and linkage problem experienced by researchers concerning health data. A researcher was requested by the Chief Medical Officer (CMO) for Wales to carry out research into the factors underlying excess winter mortality using the Secure Anonymised Information Linkage (SAIL) data bank.
  • In appendix 2 various national and international models of access to national administrative datasets
  • Seizing the data opportunity. A strategy for UK data capability (2013)
  • HM Government
  • Information Economy Council
  • E-infrastructure Leadership Council
  • Open Data Institute
  • A special reference to the “information economy”.
  • The Information Economy Council is developing a long-term strategy to drive the growth of the Information Economy sector.
  • The E-infrastructure Leadership Council to advise the government on the computing infrastructure and skills
  • Over 10,000 public datasets (including health data) published on data.gov.uk, and the ground-breaking Open Data Institute. The Open Data Institute is catalysing the evolution of open data culture to create economic, environmental, and social value.
Sweden
  • National eHealth – the strategy for accessible and secure information in health and social care (2010)
  • Ministry of Health and Social Affairs
  • National High-Level Group for eHealth
  • Ministry of Health and Social Affairs
  • Swedish Association of Local Authorities and Regions
  • Association of Private Care Providers
  • National Board of Health and Welfare
  • Famna, Swedish Association for Non Profit Health and Social Services
  • National advisory group
  • National High-Level Group for eHealth to successfully coordinate the implementation of the strategy, a National High-Level Group for eHealth has been in place since 2005.
  • A new consultative body in the form of a national advisory group was created during 2009 with the aim of preparing and formalising the dialogue with most of the key actors in the health and social care sector.
  • National Information Structure (NI) describes what kind of information is needed in health and social care documentation on the general level. It also describes how the information should be structured so that it can be used in different contexts, for different purposes, in the health and social care process and for monitoring and managing activities. The National Board of Health and Welfare has developed an initial NI version.
  • Healthcare service information in civil registries (VIF). The aim of this project is to improve the quality and service of the information exchange between the healthcare services and civil registries at the Swedish Tax Agency and to the National Board of Health and Welfare.
  • Public Performance Reports on Health Care and Social Services (2010)
  • A national strategy for quality improvement through public performance reports on health care and social services. Public performance reports are a set of indicators that are regularly reported and that describe services with regard to patient satisfaction, waits and delays, quality, prevention, safety, efficiency, etc.
Spain
  • Summary of the Strategy in Mental Health of the National Health System (2008)
  • Ministry of Health and Consumer Affairs
  • Health Institute Carlos III (research)
  • Autonomic Communities
  • Need of using tools which could allow the evaluation of the reform objectives, trying to overcome the information systems of purely administrative character. There is a reference to the current situation on Mental Health and to recommendations.
  • Minimum Basic Set of Data (CMBD) at hospital discharge.

Notes

  1. Data by May 2014, non-validated by Member States representatives

References

  1. Guidelines on minimum/nonexhaustive Patient Summary Dataset for electronic exchange in accordance with the Cross-Border Directive 2011/24/EU, Adopted by the eHealth Network, 19 November 2013. Available at: http://ec.europa.eu/health/ehealth/docs/guidelines_patient_summary_en.pdf
  2. Guidelines on ePrescriptions dataset for electronic exchange under Cross-Border Directive 2011/24/EU. Adopted by the eHealth Network, 18 November 2014. Available at: http://ec.europa.eu/health/ehealth/docs/eprescription_guidelines_en.pdf
  3. European Charter of Fundamental Rights. Homepage at: http://ec.europa.eu/justice/fundamental-rights/charter/index_en.htm
  4. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal L 281 , 23/11/1995 P. 0031 – 0050 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:HTML
  5. WP 29, Opinion 15/2011 on the definition of consent. Adopted on 13 July 2011. Available at: http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2011/wp187_en.pdf
  6. DG Justice. Reform of the data protection legal framework in the EU. http://ec.europa.eu/justice/data-protection/reform/index_en.htm
  7. The Nordic Trial Alliance Working Group 6 on Transparency and Registration. Report on transparency and registration in clinical research in the Nordic countries. March 2015. Available at: http://nta.nordforsk.org/news/final-report-on-transparency-and-registration-in-clinical-research-in-the-nordic-countries-published
  8. European Parliament legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) (COM(2012)0011 – C7-0025/2012 – 2012/0011(COD)). Available at: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2014-0212+0+DOC+XML+V0//EN
  9. ISO Metadata Standards: http://metadata-stds.org/
  10. ISO/IEC 11179: http://www.iso.org/iso/catalogue_detail.htm?csnumber=50340
  11. Dublin Core Metadata Initiative: http://dublincore.org/
  12. Data Documentation Initiative (DDI): http://www.ddialliance.org/