title: Recommendation of the European Systemic Risk Board of 5 December 2018 amending Recommendation ESRB/2015/2 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures (ESRB/2018/8)

text:
               1.2.2019

               EN

               Official Journal of the European Union

               C 39/1

      RECOMMENDATION OF THE EUROPEAN SYSTEMIC RISK BOARD
      of 5 December 2018
      amending Recommendation ESRB/2015/2 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures
      (ESRB/2018/8)
      (2019/C 39/01)
      THE GENERAL BOARD OF THE EUROPEAN SYSTEMIC RISK BOARD,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (1), and in particular Article 3 and Articles 16 to 18 thereof,
      Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (2), and in particular Article 458(8) thereof,
      Having regard to Decision ESRB/2011/1 of the European Systemic Risk Board of 20 January 2011 adopting the Rules of Procedure of the European Systemic Risk Board (3), and in particular Articles 18 to 20 thereof,
      Whereas:

                  (1)

                  In order to ensure effective and consistent national macroprudential policy measures, it is important to complement the mandatory reciprocity required under Union law with voluntary reciprocity.

                  (2)

                  The framework on voluntary reciprocity for macroprudential policy measures, set out in Recommendation ESRB/2015/2 of the European Systemic Risk Board (4), aims to ensure that the same set of macroprudential requirements apply to the same type of risk exposures in a given Member State, irrespective of the legal status and location of the financial service provider.

                  (3)

                  Recommendation ESRB/2017/4 of the European Systemic Risk Board (5) recommends the relevant activating authority to propose a maximum materiality threshold when submitting a request for reciprocation to the European Systemic Risk Board (ESRB), below which an individual financial service provider’s exposure to the identified macroprudential risk in the jurisdiction where the macroprudential policy measure is applied by the activating authority can be considered non-material. The ESRB may recommend a different threshold if deemed necessary.

                  (4)

                  As a general principle, in line with Article 458(3) of Regulation (EU) No 575/2013, the activating authority is expected to cooperate with the relevant authorities reciprocating the measure in order to ensure an efficient and effective implementation of the reciprocating measure.

                  (5)

                  From 1 July 2018, French global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter are subject, pursuant to Article 458(2)(d)(ii) of Regulation (EU) No 575/2013, to a large exposure limit of 5 per cent of their eligible capital in relation to highly-indebted large non-financial corporations having their registered office in France.

                  (6)

                  Following the request by the Haut Conseil de stabilité financière (High Council for financial stability) to the ESRB under Article 458(8) of Regulation (EU) No 575/2013, and in order to: (i) prevent the materialisation of negative cross-border effects in the form of leakages and regulatory arbitrage that could result from the implementation of the macroprudential policy measure applied in France in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013; (ii) signal to other market participants the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France; and (iii) increase the resilience of systemically important institutions in other Member States, the General Board of the ESRB has decided to include this measure in the list of macroprudential policy measures which are recommended to be reciprocated under Recommendation ESRB/2015/2.

                  (7)

                  As the measure activated by the Haut Conseil de stabilité financière is applied only at the highest level of consolidation, in line with the principle specified in sub-recommendation C(2) of Recommendation ESRB/2015/2 according to which the relevant authorities should implement the same macroprudential policy measure as the one that has been implemented by the activating authority, it should also be possible to reciprocate the measure at the same level of consolidation. In addition, applying the materiality threshold at an individual level could lead to the exemption of institutions which, at a consolidated level, have concentrated large exposures to highly-indebted non-financial corporations having their registered office in France, thereby creating an incentive for regulatory arbitrage. Consequently, the recommended materiality threshold should, in this exceptional case, be applied on a consolidated basis.

                  (8)

                  Therefore, Recommendation ESRB/2015/2 should be amended accordingly,

            HAS ADOPTED THIS RECOMMENDATION:

         AMENDMENTS

      Recommendation ESRB/2015/2 is amended as follows:

                  1.

                  in Section 1, sub-recommendation C(1) is replaced by the following:

                              ‘1.

                              The relevant authorities are recommended to reciprocate the macroprudential policy measures adopted by other relevant authorities and recommended for reciprocation by the ESRB. It is recommended that the following measures, as further described in the Annex, be reciprocated:
                              Estonia:

                                          —

                                          a 1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia;

                                    Finland:

                                          —

                                          a 15 per cent floor for the average risk-weight on residential mortgage loans secured by a mortgage on housing units in Finland applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 to credit institutions authorised in Finland, using the Internal Ratings Based (IRB) Approach for calculating regulatory capital requirements;

                                    Belgium:

                                          —

                                          a risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 to credit institutions authorised in Belgium, using the IRB Approach for calculating regulatory capital requirements and composed of:

                                                      (a)

                                                      a flat risk-weight add-on of 5 percentage points; and

                                                      (b)

                                                      a proportionate risk-weight add-on consisting of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium;

                                    France:

                                          —

                                          a tightening of the large exposure limit provided for in Article 395(1) of Regulation (EU) No 575/2013, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France to 5 per cent of eligible capital, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 to global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter.’;

                  2.

                  The Annex is replaced by the Annex to this Recommendation.

         Done at Frankfurt am Main, 5 December 2018.

            Francesco MAZZAFERRO

               The Head of the ESRB Secretariat

               on behalf of the General Board of the ESRB

         (1)  OJ L 331, 15.12.2010, p. 1.

         (2)  OJ L 176, 27.6.2013, p. 1.

         (3)  OJ C 58, 24.2.2011, p. 4.

         (4)  Recommendation ESRB/2015/2 of the European Systemic Risk Board of 15 December 2015 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures (OJ C 97, 12.3.2016, p. 9).

         (5)  Recommendation ESRB/2017/4 of the European Systemic Risk Board of 20 October 2017 amending Recommendation ESRB/2015/2 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures (OJ C 431, 15.12.2017, p. 1).

         ANNEX
         The Annex to Recommendation ESRB/2015/2 is replaced by the following:

                  ‘Annex

                     Estonia

                        1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia

                  I.   Description of the measure

                              1.

                              The Estonian measure constitutes a 1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia.

                        II.   Reciprocation

                              2.

                              Where Member States have implemented Article 134 of Directive 2013/36/EU in national law, relevant authorities are recommended to reciprocate the Estonian measure for exposures located in Estonia of domestically authorised institutions in accordance with Article 134(1) of Directive 2013/36/EU. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.

                              3.

                              Where Member States have not implemented Article 134 of Directive 2013/36/EU in national law, relevant authorities are recommended to reciprocate the Estonian measure for exposures located in Estonia of domestically authorised institutions in accordance with sub-recommendation C(2). Relevant authorities are recommended to adopt the equivalent measure within six months.

                     Finland

                        A credit institution-specific minimum level of 15 per cent for the average risk-weight on loans secured by a mortgage on housing units in Finland applicable to credit institutions using the Internal Ratings Based (IRB) Approach (hereinafter “IRB credit institutions”) under Article 458(2)(d)(vi) of Regulation (EU) No 575/2013.

                  I.   Description of the measure

                              1.

                              The Finnish measure, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013, consists of a credit institution-specific average risk-weight floor of 15 per cent for IRB credit institutions, at the portfolio level, for residential mortgage loans secured by housing units in Finland.

                        II.   Reciprocation

                              2.

                              In accordance with Article 458(5) of Regulation (EU) No 575/2013, relevant authorities of the Member States concerned are recommended to reciprocate the Finnish measure and apply it to IRB credit institutions' portfolios of retail mortgage loans secured by housing units in Finland issued by domestically authorised branches located in Finland. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.

                              3.

                              Relevant authorities are also recommended to reciprocate the Finnish measure and apply it to IRB credit institutions' portfolios of retail mortgage loans secured by housing units in Finland issued directly across borders by credit institutions established in their respective jurisdictions. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.

                              4.

                              In accordance with sub-recommendation C(2), the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the effect most equivalent to the above measure recommended for reciprocation, including adopting supervisory measures and powers laid down in Title VII, Chapter 2, Section IV of Directive 2013/36/EU. The relevant authorities are recommended to adopt the equivalent measure within four months.

                        III.   Materiality threshold

                              5.

                              The measure is complemented by a materiality threshold of EUR 1 billion exposure to the residential mortgage lending market in Finland to steer the potential application of the de minimis principle by the reciprocating Member States.

                              6.

                              In line with Section 2.2.1 of Recommendation ESRB/2015/2, relevant authorities of the Member State concerned may exempt individual IRB credit institutions with non-material portfolios of retail mortgage loans secured by housing units in Finland below the materiality threshold of EUR 1 billion. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate when an IRB credit institution exceeds the threshold of EUR 1 billion.

                              7.

                              Where there are no IRB credit institutions authorised in other Member States concerned with branches located in Finland or providing financial services directly in Finland that have exposures of EUR 1 billion or above to the Finnish mortgage market, relevant authorities of the Member States concerned may decide not to reciprocate as provided by Section 2.2.1 of Recommendation ESRB/2015/2. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate when an IRB credit institution exceeds the threshold of EUR 1 billion.

                     Belgium

                        A risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, imposed on credit institutions authorised in Belgium using the IRB Approach and applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013. The add-on is composed of two components:

                              (a)

                                    a flat risk-weight add-on of 5 percentage points; and

                              (b)

                                    a proportionate risk-weight add-on consisting of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium.

                        I.   Description of the measure

                              1.

                              The Belgian measure, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 and imposed on credit institutions authorised in Belgium using the IRB Approach, consists of a risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, which is composed of two components:

                                          (a)

                                          The first component consists of a 5 percentage point increase to the risk-weight for retail exposures secured by residential immovable property located in Belgium obtained after computing the second part of the risk-weight add-on in accordance with point (b).

                                          (b)

                                          The second component consists of a risk-weight increase of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium. The exposure-weighted average is the average of the risk-weights of the individual loans calculated in accordance with Article 154 of Regulation (EU) No 575/2013, weighted by the relevant exposure value.

                        II.   Reciprocation

                              2.

                              In accordance with Article 458(5) of Regulation (EU) No 575/2013, relevant authorities of the Member States concerned are recommended to reciprocate the Belgian measure by applying it to branches located in Belgium of domestically authorised credit institutions using the IRB Approach within the deadline specified in sub-recommendation C(3).

                              3.

                              Relevant authorities are recommended to reciprocate the Belgian measure by applying it to domestically authorised credit institutions using the IRB Approach that have direct retail exposures secured by residential immovable property located in Belgium. In accordance with sub-recommendation C(2), the relevant authorities are recommended to apply the same measure as the one that has been implemented in Belgium by the activating authority within the deadline specified in sub-recommendation C(3).

                              4.

                              If the same macroprudential policy measure is not available in their jurisdiction, the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the most equivalent effect to the above measure recommended for reciprocation, including adopting supervisory measures and powers laid down in Title VII, Chapter 2, Section IV of Directive 2013/36/EU. Relevant authorities are recommended to adopt the equivalent measure by no later than four months following the publication of this Recommendation in the Official Journal of the European Union.

                        III.   Materiality threshold

                              5.

                              The measure is complemented by an institution-specific materiality threshold of EUR 2 billion to steer the potential application of the de minimis principle by the relevant authorities reciprocating the measure.

                              6.

                              In line with Section 2.2.1 of Recommendation ESRB/2015/2, relevant authorities of the Member State concerned may exempt individual domestically authorised credit institutions using the IRB Approach having non-material retail exposures secured by residential immovable property in Belgium which are below the materiality threshold of EUR 2 billion. When applying the materiality threshold, the relevant authorities should monitor the materiality of exposures and are recommended to apply the Belgian measure to previously exempted individual domestically authorised credit institutions when the materiality threshold of EUR 2 billion is breached.

                              7.

                              Where there are no credit institutions authorised in the Member States concerned with branches located in Belgium or which have direct retail exposures secured by residential immovable property in Belgium, which use the IRB Approach and which have exposures of EUR 2 billion or above to the Belgian residential immovable property market, relevant authorities of the Member States concerned may, pursuant to Section 2.2.1 of Recommendation ESRB/2015/2, decide not to reciprocate the Belgian measure. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate the Belgian measure when a credit institution using the IRB Approach exceeds the threshold of EUR 2 billion.

                              8.

                              In line with Section 2.2.1 of Recommendation ESRB/2015/2, the materiality threshold of EUR 2 billion is a recommended maximum threshold level. Reciprocating relevant authorities may therefore instead of applying the recommended threshold set a lower threshold for their jurisdictions where appropriate, or reciprocate the measure without any materiality threshold.

                     France

                        A tightening of the large exposure limit provided for in Article 395(1) of Regulation (EU) No 575/2013, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France to 5 per cent of eligible capital, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 to global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter.

                  I.   Description of the measure

                              1.

                              The French measure, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 and imposed on G-SIIs and O-SIIs at the highest level of consolidation of their banking prudential perimeter (not at a sub-consolidated level), consists of a tightening of the large exposure limit to 5 per cent of their eligible capital, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France.

                              2.

                              A non-financial corporation is defined as a natural or legal person under private law having its registered office in France, and which, at its level and at the highest level of consolidation, belongs to the non-financial corporations sector as defined in point 2.45 of Annex A to Regulation (EU) No 549/2013 of the European Parliament and of the Council (1).

                              3.

                              The measure applies to exposures to non-financial corporations having their registered office in France and to exposures to groups of connected non-financial corporations as follows:

                                          (a)

                                          For non-financial corporations which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation in France, the measure applies to the sum of the net exposures towards the group and all its connected entities within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013;

                                          (b)

                                          For non-financial corporations which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation outside France, the measure applies to the sum of:

                                                      (i)

                                                      the exposures to those non-financial corporations having their registered office in France;

                                                      (ii)

                                                      the exposures to the entities in France or abroad over which the non-financial corporations referred to in (i) have direct or indirect control within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013; and

                                                      (iii)

                                                      the exposures to the entities in France or abroad which are economically dependent on the non-financial corporations referred to in (i) within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013.

                                    Non-financial corporations which do not have their registered office in France and which are not a subsidiary or an economically dependent entity of, and which are not directly or indirectly controlled by, a non-financial corporation having its registered office in France, therefore fall outside the scope of the measure.
                              In accordance with Article 395(1) of Regulation (EU) No 575/2013, the measure is applicable after taking into account the effect of the credit risk mitigation techniques and exemptions in accordance with Articles 399 to 403 of Regulation (EU) No 575/2013.

                              4.

                              A G-SII or an O-SII must consider a non-financial corporation having its registered office in France as large if its original exposure to the non-financial corporation, or to the group of connected non-financial corporations within the meaning of paragraph 3, is equal to or larger than EUR 300 million. The original exposure value is calculated in accordance with Articles 389 and 390 of Regulation (EU) No 575/2013 before taking into account the effect of credit risk mitigation techniques and exemptions set out in Articles 399 to 403 of Regulation (EU) No 575/2013, as reported in accordance with Article 9 of Commission Implementing Regulation (EU) No 680/2014 (2).

                              5.

                              A non-financial corporation is considered highly-indebted if it has a leverage ratio that is greater than 100 per cent and a financial charges coverage ratio that is below three, calculated at the highest level of group consolidation as follows:

                                          (a)

                                          The leverage ratio is the ratio between total debt net of cash and equity; and

                                          (b)

                                          The financial charges coverage ratio is the ratio between, on the one hand, the value added plus operating subsidies less: (i) payroll; (ii) operating taxes and duties; (iii) other net ordinary operating expenses excluding net interest and similar charges; and (iv) depreciation and amortisation, and, on the other hand, interest and similar charges.

                                    The ratios are calculated based on accounting aggregates defined in accordance with the applicable standards, as presented in the non-financial corporation's financial statements, certified where appropriate by a chartered accountant.

                        II.   Reciprocation

                              6.

                              Relevant authorities are recommended to reciprocate the French measure by applying it to domestically authorised G-SIIs and O-SIIs at the highest level of consolidation within the jurisdiction of their banking prudential perimeter.

                              7.

                              If the same macroprudential policy measure is not available in their jurisdiction, in line with sub-recommendation C(2), the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the most equivalent effect to the above measure recommended for reciprocation. The relevant authorities are recommended to adopt the equivalent measure by no later than six months following the publication of this Recommendation in the Official Journal of the European Union.

                        III.   Materiality threshold

                              8.

                              The measure is complemented by a combined materiality threshold to steer the potential application of the de minimis principle by the relevant authorities reciprocating the measure, which is composed of:

                                          (a)

                                          A threshold of EUR 2 billion for the total original exposures of domestically authorised G-SIIs and O-SIIs at the highest level of consolidation of the banking prudential perimeter to the French non-financial corporations sector;

                                          (b)

                                          A threshold of EUR 300 million applicable to domestically authorised G-SIIs and O-SIIs equalling or exceeding the threshold mentioned in (a) for:

                                                      (i)

                                                      a single original exposure to a non-financial corporation having its registered office in France;

                                                      (ii)

                                                      the sum of original exposures to a group of connected non-financial corporations, which has its registered office at the highest level of consolidation in France, calculated in accordance with paragraph 3(a);

                                                      (iii)

                                                      the sum of original exposures to non-financial corporations having their registered office in France which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation outside France as reported in templates C 28.00 and C 29.00 of Annex VIII to Implementing Regulation (EU) No 680/2014;

                                          (c)

                                          A threshold of 5 per cent of the G-SII's or O-SII's eligible capital at the highest level of consolidation, for exposures identified in (b) after taking into account the effect of the credit risk mitigation techniques and exemptions in accordance with Articles 399 to 403 of Regulation (EU) No 575/2013.

                                    The thresholds referred to in paragraphs (b) and (c) are to be applied irrespective of whether the relevant entity or non-financial corporation is highly-indebted or not.
                              The original exposure value referred to in paragraphs (a) and (b) is to be calculated in accordance with Articles 389 and 390 of Regulation (EU) No 575/2013 before taking into account the effect of credit risk mitigation techniques and exemptions set out in Articles 399 to 403 of Regulation (EU) No 575/2013 as reported in accordance with Article 9 of Implementing Regulation (EU) No 680/2014.

                              9.

                              In line with Section 2.2.1 of Recommendation ESRB/2015/2, the relevant authorities of the Member State concerned may exempt domestically authorised G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter which do not breach the combined materiality threshold referred to in paragraph 8. When applying the materiality threshold, the relevant authorities should monitor the materiality of the exposures of domestically authorised G-SIIs and O-SIIs to the French non-financial corporations sector as well as the exposure concentration of domestically authorised G-SIIs and O-SIIs to large non-financial corporations having their registered office in France, and are recommended to apply the French measure to previously exempted domestically authorised G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter when the combined materiality threshold referred to in paragraph 8 is breached. Relevant authorities are also encouraged to signal the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France to other market participants in their jurisdiction.

                              10.

                              Where there are no G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter authorised in the Member States concerned and having exposures to the French non-financial corporations sector above the materiality threshold referred to in paragraph 8, the relevant authorities of the Member States concerned may, pursuant to Section 2.2.1 of Recommendation ESRB/2015/2, decide not to reciprocate the French measure. In this case the relevant authorities should monitor the materiality of the exposures of domestically authorised G-SIIs and O-SIIs to the French non-financial corporations sector as well as the exposure concentration of domestically authorised G-SIIs and O-SIIs to large non-financial corporations having their registered office in France, and are recommended to reciprocate the French measure when a G-SII or O-SII at the highest level of consolidation of its banking prudential perimeter exceeds the combined materiality threshold referred to in paragraph 8. Relevant authorities are also encouraged to signal the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France to other market participants in their jurisdiction.

                              11.

                              In line with Section 2.2.1 of Recommendation ESRB/2015/2, the combined materiality threshold referred to in paragraph 8 is a recommended maximum threshold level. Reciprocating relevant authorities may therefore instead of applying the recommended threshold set a lower threshold for their jurisdictions where appropriate, or reciprocate the measure without any materiality threshold.

            ’

            (1)  Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1).

            (2)  Commission Implementing Regulation (EU) No 680/2014 of 16 April 2014 laying down implementing technical standards with regard to supervisory reporting of institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council (OJ L 191, 28.6.2014, p. 1).


title: Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (Text with EEA relevance.)

text:
               11.2.2019

               EN

               Official Journal of the European Union

               L 39/18

      COMMISSION RECOMMENDATION (EU) 2019/243
      of 6 February 2019
      on a European Electronic Health Record exchange format
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
      Whereas:

                  (1)

                  Citizens have the right to access their personal data, including their health data as provided for by Regulation (EU) 2016/679 of the European Parliament and of the Council (1), which lays down the conditions for lawful processing of personal data, including data concerning health, as defined therein (2) (health data). However most citizens cannot yet access (nor securely share) their health data across borders.

                  (2)

                  The ability of citizens and healthcare providers to securely access and share electronic health records (‘EHR's), that is to say collections of longitudinal medical records or similar documentation of an individual, in digital form, within and across borders has a number of benefits: an improvement in the quality of care for citizens, reduction in the cost of healthcare to households, and it supports the modernisation of health systems in the Union that are under pressure from demographic changes, rising expectations and costs of treatment. For example, sharing the results of blood tests in a digital format among clinical teams prevents repeating invasive and costly tests on the same person. Similarly, where patients need to see different health professionals, sharing electronic health records can avoid a repetition of the same information about their medical history saving time for all parties involved and improving the quality of care.

                  (3)

                  Enabling the secure access and sharing of health records across borders in the Union will facilitate citizens' life in a number of cross-border situations, such as citizens, and their families, who are currently living in another Member State for work purposes or retired people living in another country, enabling them to have access to health records between the Member States in which they have been resident. It will also improve the quality of care in situations which require medical treatment while travelling in the Union or as part of a cross border agreement. There are over two million recorded instances a year where a citizen living in one Member State has sought healthcare in another (3). Moreover, in the future, it can be usefully linked to European Union initiatives in the field of social security coordination.

                  (4)

                  Healthcare needs are expected to further increase in the future as a result of population ageing, rising prevalence of chronic conditions and a rise in demand for long-term care. This is evidenced by health spending amounting to 9,6 % of Gross Domestic Product in the Union as a whole in 2017, up from 8,8 % in 2008 (4). Similarly, evidence from various countries suggest that up to 20 % of healthcare spending is wasteful, for example because patients receive unnecessary tests or treatments, or as a result of avoidable hospital admissions.

                  (5)

                  Digital technologies are powerful solutions to address those issues and to adapt health systems to future challenges. For example, digital solutions linked to health apps, or wearable devices, combined with a system that allows a citizen secure access to their own health data, should enable patients with chronic conditions, such as diabetes, or cancer, to monitor their own symptoms at home and share them quickly with their clinical teams. This should reduce the number of visits to a health facility for monitoring. Digital technologies can also help to detect early a need for a change in treatments, resulting in fewer hospitalisations due to complications. Better management of chronic conditions in the community, alongside reducing duplication of healthcare actions (such as tests) should not only make systems more sustainable but also improve overall quality of life, the quality of healthcare provided to citizens, and reduce the costs associated with healthcare for individuals and households.

                  (6)

                  The Council has regularly called for Member States to strengthen the implementation of their digital health strategies. In particular, the Council conclusions on Health in the Digital Society adopted on 8 December 2017 (5) stress the need for Member States to make their electronic health systems more interoperable in order to give citizens greater control over their health data.

                  (7)

                  To support the digital transformation of health and care, the Commission adopted the Communication on ‘enabling the digital transformation of health and care in the Digital Single Market: empowering citizens and building a healthier society’ (6). That Communication adapts for the health sector, the objectives set out in the Communication ‘A Digital Single Market Strategy for Europe’ adopted on 6 May 2015 (7) and the Communication ‘EU eGovernment Action Plan — Accelerating the Digital Transformation of Government’, adopted on 19 April 2016 (8). It addresses the concerns raised in the Communication on the Mid-Term Review on the implementation of the Digital Single Market Strategy, ‘A Connected Digital Single Market for All’ (9) regarding the fact that the uptake of digital solutions for health and care remains slow and varies significantly across the Member States and regions.

                  (8)

                  Digitising health records, and creating systems that enable them to be securely accessed by citizens and securely shared within and between the different actors in the health system (patients, their clinical teams in the community and hospital facilities) is an important step towards integrating digital technologies into health and care approaches. That integration requires electronic health records, to be interoperable across the Union whereas currently many of the formats and standards in electronic health record systems — that are information systems for recording, retrieving and managing electronic health records — used across the Union are incompatible.

                  (9)

                  New technologies for health should support citizens to become active agents of their own health journey. To this end, citizens' and patients' needs should be taken into account when designing health information systems including making these systems more accessible to users, in particular to persons with disabilities, according to the accessibility requirements laid down by Directive (EU) 2016/2102 of the European Parliament and of the Council (10), where applicable

                  (10)

                  The aim of interoperability with regard to electronic health records is to allow for the processing of information in a consistent manner between those health information systems, regardless of their technology, application or platform in a way that it can be meaningfully interpreted by the recipient.

                  (11)

                  The lack of interoperability with regard to electronic health records leads to fragmentation and a lower quality of cross-border healthcare provision. The Commission has already identified specific ‘Integrating the Healthcare Enterprise’ (IHE) profiles listed in the Annex to Commission Decision (EU) 2015/1302 (11) (12) with the potential to increase interoperability of eHealth services and applications to the benefit of citizens and the healthcare professional community and to be eligible for referencing in public procurement. Those profiles provide detailed specifications for different layers of interoperability. Some of those profiles are already used to address specific business requirements in the eHealth Digital Service Infrastructure (‘eHDSI’).

                  (12)

                  The highest possible standards for security and data protection are central to developing and exchanging electronic health records. The General Data Protection Regulation requires patient data to be protected and properly secured so that its confidentiality, integrity and availability are ensured. As a consequence, systems must be secure, safe, trustable and integrate data protection by design and by default. A series of European wide digital solutions and common approaches for government and institutions lay the basis for this.

                  (13)

                  The use of secure electronic identification and authentication means provided for in Regulation (EU) No 910/2014 of the European Parliament and of the Council (13) (eIDAS) should enhance access, security and trust in electronic health record systems. That Regulation lays down the conditions under which recognised electronic identification means, falling under a notified electronic identification scheme of a Member State, may be used by citizens to gain access to online public services from abroad, including access to health services and health data. It also lays down rules for trust services such as electronic signatures, electronic seals and electronic registered delivery services, to securely manage and exchange health data by minimising the risk of possible tampering and misuse.

                  (14)

                  Under Directive (EU) 2016/1148 of the European Parliament and of the Council (14) healthcare providers, that are identified as operators of essential services by Member States and digital service providers falling in its scope are required to take appropriate and proportionate technical and organisational measures to manage the risks posed to the security of network and information systems they use in their operations of provision of service. They are also required to notify security incidents having a significant or substantial impact on the continuity of the services they provide to the competent national authorities or to the national Computer Security Incident Response Teams (CSIRTs). As regards in particular cybersecurity for electronic health record systems, cybersecurity certification may allow the demonstration that cybersecurity requirements are fulfilled, under the relevant Union cybersecurity framework (15).

                  (15)

                  Member States have taken important steps to foster interoperability with the support of the Commission, through the activities of the eHealth Network established under Article 14 of Directive 2011/24/EU. The eHealth Network's main objective is to support the development of sustainable eHealth systems, services and interoperable applications, facilitate cooperation and the exchange of information among Member States, enhance continuity of care and ensure access to safe and high-quality healthcare. Consequently it plays a crucial role for the interoperability of electronic health records.

                  (16)

                  In particular, in order to facilitate the interoperability of European eHealth systems, a number of Member States participating in the eHealth Network have worked together with the Commission to build the eHealth Digital Services Infrastructure, supported by the Connecting Europe Facility (CEF) Programme (16). In some of those Member States, the exchange of ‘ePrescriptions’ between health professionals across borders through the eHealth Digital Services Infrastructure has started, while the exchange of ‘Patient Summaries’ is expected to start soon. Enhancing the interoperability of electronic health records should help expanding the datasets currently being exchanged within the eHealth Digital Services Infrastructure to include valuable information concerning laboratory results, medical imaging and reports, and hospital discharge reports, which would enhance continuity of care. A number of tools developed for the eHealth Digital Services Infrastructure are a resource for Member States for the exchange of electronic health records.

                  (17)

                  In the context of exchanging electronic health records, the eHealth Network plays a valuable role in further developing the European electronic health record exchange format, by using it for the eHealth Digital Services Infrastructure and promoting its use for exchanges between healthcare providers at national level.

                  (18)

                  Digitising health records and enabling their exchange could also support the creation of large health data structures which combined with the use of new technologies, such as big data analytics and artificial intelligence can support the search for new scientific discoveries.

                  (19)

                  Existing national specifications for electronic health record systems may continue to apply in parallel with a European electronic health record exchange format,

            HAS ADOPTED THIS RECOMMENDATION:

         OBJECTIVES

                  (1)

                  This Recommendation sets out a framework for the development of a European electronic health record exchange format in order to achieve secure, interoperable, cross-border access to, and exchange of, electronic health data in the Union.
                  The framework includes:

                              (a)

                              a set of principles that should govern access to and exchange of electronic health records across borders in the Union;

                              (b)

                              a set of common technical specifications for the cross-border exchange of data in certain health information domains, which should constitute the baseline for a European electronic health record exchange format;

                              (c)

                              a process to take forward the further elaboration of a European electronic health record exchange format.

                        It also encourages Member States to ensure secure access to electronic health record systems at national level.

         ELECTRONIC HEALTH RECORD SYSTEMS IN MEMBER STATES

         Ensuring secure access to electronic health record systems

                  (2)

                  Member States should ensure that electronic health record systems meet high standards for the protection of health data, and the security of network and information systems on which such electronic health record systems rely, to avoid data breaches and minimise the risks of security incidents.

                  (3)

                  Member States should ensure that citizens and their healthcare professionals have online access to their electronic health records using secure electronic identification means, taking into account the framework for security and trust established by the Regulation (EU) No 910/2014.

         Tools and incentives

                  (4)

                  Member States should use the tools and building blocks provided by the eHealth Digital Services Infrastructure supported under the Connecting Europe Facility Programme and refer to the Refined eHealth European Interoperability Framework (17) as the common framework for managing interoperability in the eHealth domain.

                  (5)

                  Member States should take appropriate measures to support the use of interoperable electronic health record systems such as leveraging dedicated financial investments, including incentive mechanisms, and adapting legislation where appropriate.

         National digital health networks

                  (6)

                  To enhance the interoperability and security of national health systems and support the secure exchange of health data across borders, each Member State should set up a national digital health network involving representatives of the relevant competent national authorities and, where appropriate, regional authorities dealing with digital health matters and the interoperability of electronic health records, and security of networks and information systems, and the protection of personal data. In particular national digital health networks should involve the following:

                              (a)

                              the national representative of the eHealth Network;

                              (b)

                              national, or regional, authorities with clinical and technical competence for digital health matters;

                              (c)

                              supervisory authorities established under Article 51 of Regulation (EU) 2016/679;

                              (d)

                              competent authorities designated pursuant to Directive (EU) 2016/1148.

                  (7)

                  The results of discussions or consultations of the national digital health networks should be transmitted to the eHealth Network and to the Commission.

         FRAMEWORK FOR CROSS-BORDER EXCHANGE OF ELECTRONIC HEALTH RECORDS

         Principles for access to and cross-border exchange of electronic health records

                  (8)

                  Member States should ensure that citizens are able to access and securely share their electronic health data across borders.

                  (9)

                  Member States are encouraged to give citizens the ability to choose to whom they provide access to their electronic health data, and which health information details are shared.

                  (10)

                  Member States should ensure that the principles set out in the Annex are observed when developing solutions enabling access to, and exchange of electronic health data in the Union.

         Baseline for a European electronic health record exchange format

                  (11)

                  Member States should take measures to ensure that the following health information domains, as a baseline, are part of a European electronic health record exchange format:

                              (a)

                              Patient Summary;

                              (b)

                              ePrescription/eDispensation;

                              (c)

                              Laboratory results;

                              (d)

                              Medical imaging and reports;

                              (e)

                              Hospital discharge reports.

                        The cross-border exchange of information should take place in accordance with the baseline standards, interoperability specifications and the profiles depending on the health information domain as set out the Annex.

         Further elaboration of a European electronic health record exchange format

                  (12)

                  Member States should, in the context of Article 14 of Directive 2011/24/EU and in collaboration with the Commission, support the further elaboration of the recommended baseline of health information domains and specifications for a European electronic health record exchange format, through a joint coordination process.

                  (13)

                  Through this process, Member States, supported by the Commission, should engage in discussions and cooperation at Union level with relevant stakeholders, including healthcare professional organisations, national competence centres, industry actors and patient groups, as well as other Union and national authorities with competence in relevant areas to encourage, and contribute to, an iterative process of further elaborating and adopting a European electronic health record exchange format. In particular, clinical and technical experts should be involved in work concerning technical and semantic specifications for cross-border exchange of health data. The results of these discussions and consultations should be transmitted to the eHealth Network.

                  (14)

                  The joint coordination process should benefit from knowledge available in national competence centres targeting the identification of the meaningful medical concepts for each given context.

                  (15)

                  The joint coordination process should take forward approaches that all Member States can support, while Member States that so wish may progress towards electronic health record interoperability at a faster speed.

                  (16)

                  The joint coordination process should build on, and incorporate the results of, existing initiatives of the eHealth Network such as the Common Semantic Strategy task force.

                  (17)

                  Member States, in the context of the eHealth Network, should cooperate with the Commission and other relevant stakeholders in establishing practical implementation guidelines, sharing good practice and promoting awareness actions for citizens and healthcare providers on the benefits of access to, and exchange of electronic health record, across borders. Pilot projects including research, innovation or deployment actions, such as those supported under the Horizon 2020 (18) and Connecting Europe Facility Programmes, where relevant, should be used to advance interoperability and raise awareness.

         MONITORING AND FUTURE DEVELOPMENTS

         Monitor progress towards interoperability

                  (18)

                  Member States, in the context of the eHealth Network and in cooperation with the Commission, should monitor progress towards interoperability on the basis of a shared roadmap revised annually, identifying common priorities, tasks, deliverables and milestones.
                  For that purpose, Member States should, on a yearly basis:

                              (a)

                              share information on the measures they have taken to support the adoption of the specifications of the European electronic health record exchange format;

                              (b)

                              identify common priorities and synergies with national strategies to improve cross-border exchange of electronic health records.

                  (19)

                  The elements referred to in points 18(a) and (b) should be taken into account when assessing the next steps for the exchange of electronic health records across the Union.

         Future work

                  (20)

                  Member States should engage with the Commission and relevant stakeholders to identify and review emerging technological and methodological innovation and identify appropriate steps to achieve progress in the long-term exchange of electronic health records.

         Assessment of the effects of the Recommendation

                  (21)

                  Member States should cooperate with the Commission to assess the effects of this Recommendation taking into account their experience and any relevant technological developments with a view to determine appropriate ways forward.

         Done at Brussels, 6 February 2019.

               For the Commission

            Mariya GABRIEL

               Member of the Commission

         (1)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

         (2)  Article 4(15) of the General Data Protection Regulation.

         (3)  Either using a European Health Insurance Card or under the Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

         (4)  ‘Health at a Glance: Europe 2018 — State of Health in the EU Cycle’ https://ec.europa.eu/health/sites/health/files/state/docs/2018_healthatglance_rep_en.pdf

         (5)  2017/C 440/05.

         (6)  COM(2018) 233 final.

         (7)  COM(2015) 192 final.

         (8)  COM(2016) 179 final.

         (9)  COM(2017) 228 final.

         (10)  Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1) (Web Accessibility Directive).

         (11)  Commission Decision (EU) 2015/1302 of 28 July 2015 on the identification of ‘Integrating the Healthcare Enterprise’ profiles for referencing in public procurement (OJ L 199, 29.7.2015, p. 43).

         (12)  https://www.ihe.net/ and https://www.ihe-europe.net/

         (13)  Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).

         (14)  Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1).

         (15)  See Joint Communication on Resilience, Deterrence and Defence: Building strong cybersecurity for the EU, point 2.2 (JOIN(2017) 450 final).

         (16)  https://ec.europa.eu/cefdigital/wiki/display/EHOPERATIONS/eHealth+DSI+Operations+Home

         (17)  https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20151123_co03_en.pdf

         (18)  https://ec.europa.eu/programmes/horizon2020/en/

         ANNEX
         1.   Principles

         (a)   Citizen-centric by design

         Citizens should be central to the way in which systems are designed. Such systems are to be designed to implement the principles of data protection by design and by default to meet the requirements of the General Data Protection Regulation.
         (b)   Comprehensiveness and machine-readability

         Electronic health records should be as comprehensive as possible in order to support health and care services throughout the Union.
         Health data introduced in electronic health records should be machine-readable to the extent required by reasonable intended reuse of those data. Information should be structured and codified in the most practical way possible, with a view to making health data interoperable, including across borders.
         (c)   Data protection and confidentiality

         Electronic Health Record systems and interoperability solutions have to guarantee the confidentiality of personal health data and conform with all aspects of data protection legislation, from their design stage onward.
         The fundamental right to the protection of personal data should be fully and effectively implemented, in conformity with Regulation (EU) 2016/679, including the right to transparent information, the right of access and other relevant rights listed in Chapter III. In particular, citizens should be able to exercise their right to access their health data by having access to their electronic health records, including across borders.
         (d)   Consent or other lawful basis

         Any processing (1) of health data must be based on the explicit consent of the citizen concerned or on any other lawful basis, pursuant to Articles 6 and 9 of Regulation (EU) 2016/679.
         (e)   Auditability

         Any processing of health data should be registered and verified for auditing purposes, using appropriate techniques, such as logging and audit trailing, to keep an accurate record of the access to electronic records, their exchange or any other processing operation.
         (f)   Security

         Pursuant to Regulation (EU) 2016/679 and Directive (EU) 2016/1148 appropriate technical and organisational measures must be implemented to ensure that electronic health record systems are secure. Those measures should include protection against unauthorised or unlawful processing of health data and against accidental loss, destruction or damage. Entities exchanging electronic health records should ensure that personnel dealing with electronic health records systems is properly aware of cybersecurity risks and adequately trained.
         (g)   Identification and authentication

         Strong and reliable identification and authentication of all involved parties is a key element to guarantee trust in exchanges of data between electronic health record systems.
         The use of notified national electronic identifications (‘eID's) supports citizens’ cross-border identification and authentication to access their health data in full security and convenience, as well as the principle of ‘non-repudiation’ assuring the origin and integrity of such data. Through the mutual recognition of national electronic identification schemes, as foreseen in Regulation (EU) No 910/2014, citizens of one Member State may use their national electronic identifications to securely access online services provided to them in another Member State. Pursuant to Article 6 of that Regulation, online public services requiring electronic identification assurance corresponding to a certain level (‘substantial’ or ‘high’) must accept the notified electronic identification schemes of other Member States.
         (h)   Continuity of service

         Continuity and availability of the electronic health record exchange service is essential to guarantee continuity of care. Any incidents or interruptions that may arise in the course of the use of the service should be promptly addressed in accordance with defined business continuity plans.
         2.   Baseline for the European electronic health record exchange format: health information domains and specifications for cross-border exchange of electronic health records

         The baseline for the European electronic health record exchange format should include the health information domains and interoperability specifications (including standards, and profiles (2)) mentioned below for representing and exchanging (structured and unstructured) health data.
         This baseline should be further refined and extended through a joint coordination process. Additional international standards, specifications and profiles, currently being developed, under revision or in trial implementation phase should be considered in further developing a European electronic health record exchange format.
         2.1.   Health information domains for cross-border exchange

         The initial set of health information domains for cross-border exchange should include the following:

                     (i)

                     Patient Summaries (3)

                     (ii)

                     ePrescriptions/eDispensations (4)

                     (iii)

                     Laboratory reports

                     (iv)

                     Medical images and reports

                     (v)

                     Hospital discharge reports.

               These health information domains have been prioritised in alignment with the eHealth Network established priorities, on the basis of current work under the eHealth Digital Services Infrastructure and clinical relevance for cross-border healthcare.
         2.2.   Interoperability specifications

         Tables A and B contain a set of recommended interoperability specifications for content structuring and representation.
         2.2.1.   Table A: Content structuring and representation for health information domains for which the eHealth Network have adopted guidelines

                     Health information domains

                     Clinical information for cross-border exchange

                     Content representation for cross-border exchange

                     Patient Summary

                     Structured according to the provisions in the ‘GUIDELINE on the electronic exchange of health data under Cross-Border Directive 2011/24/EU Release 2 — Patient Summary for unscheduled care’ adopted by the eHealth Network on 21 November 2016 (5)

                     Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 (6)

                     Level 3 and Level 1 (PDF (7)/A)

                     ePrescription/eDispensation

                     Structured according to the provisions in the ‘GUIDELINE on the electronic exchange of health data under Cross-Border Directive 2011/24/EU Release 2 — ePrescriptions and eDispensations’ adopted by the eHealth Network on 21 November 2016 (8)

                     Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2
                     Level 3 and Level 1 (PDF (7)/A)

               2.2.2.   Table B: Content structuring and representation for other health information domains

                     Health information domain

                     Clinical information for cross-border exchange

                     Content representation for cross-border exchange

                     Laboratory results

                     Enable cross-border exchange according to the clinical information structure currently used by the sender electronic health record system, while common clinical information structures for cross-border exchange are developed and agreed.

                     For laboratory results, medical imaging reports and hospital discharge reports
                     Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2
                     Level 3 or Level 1 (PDF (9)/A)
                     For medical imaging
                     Digital Imaging and Communications in Medicine (DICOM)

                     Medical imaging and reports

                     Hospital discharge reports

               2.2.3.   Cross-border exchange profiles

         The use of relevant ‘Integrating the Healthcare Enterprise’ profiles listed in the Annex to Decision (EU) 2015/1302 should be duly considered to facilitate the exchange of healthcare information domains across borders.
         Those ‘Integrating the Healthcare Entreprise’ profiles could be used, inter alia, for patient identification, document exchange, audit trails and identity claims.
         The joint coordination process should also consider other ‘Integrating the Healthcare Entreprise’ profiles currently at trial stage, or any other standards or specifications needed to address the requirements for secure health data exchange, as well as other types of message exchange patterns.
         3.   Future work

         The aim is to deliver the right data, at the right time — for citizens and healthcare providers — and allow for the secure access, sharing and exchange of electronic health records.
         As such, working towards comprehensive cross-border exchange of electronic health records in a fast changing, connected environment requires regular review of the latest technological and methodological innovations to managing data, including those related to accessing and leveraging of advanced technological infrastructures.
         The refinement of the exchange format should consider the possibility offered by resource driven information models (such as Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR©) (10)).
         In order to make further progress, a review of new approaches to interoperability specifications, such as relevant Application Programming Interfaces (‘API's) and developments in digital technologies such as artificial intelligence, cloud computing, interaction technologies, high performance computing and cyber security solutions should be carried out. Evolution in other technologies such as distributed ledger technologies may have the potential to build trust amongst citizens and health care organisations provided that they comply with personal data protection rules.
         The above technologies should be considered with a view to supporting innovation in health care service provision, offering new possibilities to address issues such as health data provenance, and automated integrity assurance.

            (1)  As defined in Article 4(2) of the General Data Protection Regulation.

            (2)  The way in which standards can be implemented to meet specific clinical needs.

            (3)  https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf

            (4)  https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co091_en.pdf

            (5)  https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf

            (6)  http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7

            (7)  Portable Document Format.

            (8)  https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co091_en.pdf

            (9)  Portable Document Format

            (10)  http://hl7.org/fhir/