sou · GUB382 · 2007-01-01 00:00:00 — En för- utsättning för sådant uppgiftslämnande är att den enskilde på grund av sitt hälsotillstånd eller av annat skäl inte kan samtycka till att uppgiften lämnas ut. Undantaget får inte tillämpas rutinmässigt. Då det i enskilda fall används, skall det ske med urskillning och var- samhet. Den enskildes samtycke skall i första hand utverkas. Undan- tagsbestämmelsen har tagits in i 7 kap. 1 d § sekretesslagen. För att möjliggöra kvalitetsregisterförares långtidsuppföjning av vårdkvalitet, föreslås en utvidgning av undantagen från den absoluta statistiksekretessen i 9 kap. 4 § sekretesslagen att omfatta också upp- gift om avlidna och som rör dödsorsak eller dödsdatum. Sådana upp- gifter föreslås få lämnas ut för ändamålet kvalitetssäkring av hälso- och sjukvård som bedrivs genom nationella eller regionala kvalitets- register, om det står klart att ett utlämnande kan ske utan att den enskilde eller någon närstående till den enskilde lider skada eller men. En del ytterligare ändringar av i huvudsak redaktionell art före- slås i sekretesslagen. Våra förslag föranleder en del följdändringar i lagen (2001:499) om omskärelse av pojkar, lagen (2002:297) om biobanker i hälso- och sjukvården m.m. och lagen (2005:225) om rättsintyg i anledning av brott. Our proposals involve the cohesive regulation of the processing of personal data within the health and care services in a com- pletely new act, the Act. The proposed rules mean that the Act (1985:562) and the Health Care Register Act (1998:544) are replaced by the new Act. The new Act, which applies to all care providers, regardless of who is the manager, regulates, among other things, such issues as the obligation to keep patient records, internal secrecy and electronic access within a care provider's operation, the disclosure of data and documents through direct access or by other electronic means, and national and regional quality registers. Moreover, we propose amendments to, among other things, the secrecy legislation within the area of the health and care services. This statutory proposal partially has the character of framework legislation and specifies the fundamental principles to apply for in- formation management regarding data on patients within all health and care services. It should be possible to make more de- tailed regulations on certain general issues through ordinances or, following authorisation by the Government, through public authority regulation. These proposals may be viewed as part of the ongoing process to, with the aid of IT, establish better cooperation between the stakeholders in the health and care services and improve patient orientation in the operation. The central point of departure for the proposals is to establish regulation that facilitates both enhanced patient security and strong protection of privacy. A precondition for this is that we do not abandon the principle that health and care should be based on respect for the patients' self-determination and privacy. There would otherwise be a risk of citizens losing confidence in the health and care services over time. Scope of the Act, etc. Act applies to the core operations of care providers Act will be applied when processing personal data in the care provider's core operation, which means the provision of health and care for patients, including dental care. A 'care provider' refers to a government authority, county council and municipality as regards such health and care services that the authority, county council or municipality are responsible for and also other legal or natural persons who professionally conduct health and care. All automated processing and certain manual processing of personal data is covered The scope of the Patient completely or partially embraces the processing of personal data and the manual processing of per- sonal data that is included in, or is intended to be included in, a structured compilation of personal data that is available for searching or compilation according to special criteria. This regulation is con- sequently not limited to special computerised registers, databases or other electronic compilations of data within the health and care services. However, there are certain special provisions regarding national and regional quality registers; see below. Act supplements the Act (1998:204), which means that when the Act does not contain any relevant rules, the provision of the Act will apply. Certain provisions of the Act, among other things, those relating to documentation etc. contained in patient records, also apply if the processing is con- ducted entirely manually without the personal data forming part or being intended to form part of any structured compilation of data. In appropriate parts, the Act shall also apply in relevant respects to the processing of data relating to deceased persons. The rules of the Act apply when the operation is not covered by the Act The processing of personal data in operations that fall outside the scope of the Act should be regulated in precisely the same way as they currently are by the Act. Such ope- rations include, for example, operations conducted by patient boards and pharmaceutical committees. There are care providers within the scope of the Act who also process personal data that falls outside the scope of the Act. For instance, such data may relate to purely administrative operations that are not directly linked to the patient operation. Such special personal data processing that occurs ex- clusively for the purposes of research or education consequently falls outside the scope of the Act The purpose of the processing of personal data, etc. The purposes for which personal data, according to the proposed Act, may be gathered and also otherwise processed within health and care services are: 1.maintenance of patient records and other documentation that is necessary for the care of patients or that is necessary for admi- nistration relating to patients and aims to afford care in a parti- cular case or which otherwise results from care in an individual case (Care documentation), 2.preparation of other documentation, as prescribed by act, ordi- nance or other legislation, 3.systematic and ongoing development and of the quality of the health and care services (Quality ), 4.administration, planning, follow-up, evaluation and supervision of the health and care operations, and 5.preparation of statistics relating to health and care. In addition to this, personal data processed for purposes according to items 1–5 may be processed to satisfy the provision of data re- quired to comply with act or ordinance. Otherwise, the 'principle of finality' contained in Section 9, first paragraph, item d of the Act applies. This means that personal data that al- ready exists in health and care service operations may be processed for purposes other than those for which they have been gathered, subject to the precondition that the new purposes are compatible with the previous purposes. No special provisions on combined runs are proposed. Combined runs are consequently permitted provided, among other things, they fall within the frame of one or more of the purposes stated in the Act. Act states that a care provider is the personal data controller for the processing of personal data conducted. At the county councils and municipalities, an authority is the personal data controller for the processing of personal data that the authority con- ducts. The Act also contains certain special provisions on personal data liability in the case of the maintenance of composite records and in the case of the maintenance of registers in the national and regional quality register. Personal data that may be processed Only such personal data as is necessary for the purpose for which the processing of personal data is conducted may be processed accor- ding to the Act. It is made clear in the Act that data about legal offences etc., as referred to in Section 21 of the Act, may also be processed in the operations of private care providers. Otherwise, no special provision is proposed regarding such personal data categories as are specially regulated by the Act. The position of the individual on the processing of personal data It is prescribed in the Act that the processing of personal data under the Act may also occur even if the individual opposes the processing of personal data. There may be exemptions to this main rule according to act or ordinance. Act pro- vides for some such exemptions. Put simply, these exemptions relate to situations where an individual is given an opportunity to impede data about them being disseminated within the health and care services. It is also made clear that processing of personal data extending beyond that allowed by the Act may also be conducted, provided the individual has explicitly consented to such processing and unless otherwise prescribed by other provisions of the Act or by another act or ordinance. Restrictions on search terms According to the Act, sensitive personal data, as re- ferred to in Section 13 of the Act, and personal data on legal offences, etc., as referred to in Section 21 of the same Act, may not be used as search terms. may data about someone having received assistance or other measures within the social ser- vices or having been the subject of measures under the Aliens Act (2005:716) be used as search terms. However, there are exemptions from this prohibition regarding data relating to health or data about someone having been the subject of compulsory intervention under the Compulsory Mental Care Act (1991:1128) or the Act on Forensic Psychiatric Care (1991:1129). Such data may consequently be used as search terms if this is necessary for any permitted purpose. Furthermore, provided the Government makes rules on the matter, a county council or municipality may use personal data on ethnicity and data on some- one having received assistance or other initiatives within the social services or been the subject of measures under the Aliens Act as a search term in order to effect certain kinds of compilations. New regulation of the maintenance of patient records We propose that the numerous provisions contained in the Act are transferred basically unchanged to the Act. This applies to provisions regarding: requirements to maintain records; on who is liable to keep patient records; on the obligation to issue a certificate concerning care on the request of the patient; on correction of record information; on the destruction of records; on notes in records where a record is disclosed and the taking into care of patient records within the private health and care services; on the return of records taken into care; on the preservation of records; and signing requirements. However, a provision is pro- posed authorising the Government, or the authority appointed by the Government, to make regulations on exemptions from the signing requirement. It is also proposed that some of the provisions con- tained in the Act on what information a patient record should contain should be transferred to the Act. The provisions of the Act, providing for records drawn up within the health and care services to be, as a main rule, written in Swedish, are transferred to the Act. We further propose that a provision be introduced to the Act regarding what a patient record may contain. This provision corresponds to the current rule contained in the Health Care Register Act about what a health care register may contain. We also propose that if a patient considers information in the record to be incorrect or misleading, that this should be noted in the patient record. Act also contains a provision corresponding in part with the provision contained in the Patient about information in patient records drawn up by the health and care services being formulated so that the privacy of the patient is respected. However, in the Act, the provision has been given a wider scope and applies to all formulation of personal data; that is to say not just in connection with maintaining records. A composite record? We have, among other things, been directed to analyse the con- ditions for and the benefit of all care providers – throughout or within a county council district – having a composite patient record for each patient. Notwithstanding the rapid development taking place within the IT sector, the fundamental preconditions do not currently prevail in our opinion for the introduction of a com- posite record for each patient for all care providers. Legislation on an obligation to maintain records in a composite system are there- fore not feasible and cannot be recommended. do we consider that it would be appropriate at this moment in time to introduce such a mandatory comprehensive system. In our opinion, it is also uncertain whether, and in that case when, composite patient records of a more limited kind could possibly be arranged. In line with this, it is not proposed that any obligation should be introduced to main- tain records across care provider boundaries in any area. We also reject a new system that would entail the patient owning their record or that the record should no longer be linked to the care provider in whose operation the maintenance of the records occurs. Maintenance of composite records Direct access for care provider – maintaining composite records We propose that a rule be introduced into the Act whereby care providers – subject to certain conditions – may gain direct access to each other's electronic records and other personal data that is processed for purposes relating to care documentation. 'Direct access' means that data is disclosed to an external recipient, in this case another care provider, by authorised personnel at the latter care provider being given the opportunity to, on their own initiative, make arrangements for and gain electronic access to data held by the releasing party. This regulation makes it possible for health care managers and private care providers to develop different kinds of systems for the maintenance of composite records. Through the maintenance of composite records, accessibility is provided to patient data that in practice allows the information to follow the patient in various care chains and care processes. The aim of this system is pri- marily to, through the use of IT, enhance patient benefit in the form of increased patient security. However, the Act does not regulate the kinds of technical solutions or organisational structure chosen for the maintenance of composite records. In our opinion, the Freedom of the Press Act does not impede the authorities of the health and care services participating in the maintenance of composite records. The patient's influence in the maintenance of composite records Our point of departure is that the patient must be provided with influence regarding the possibility of other care providers gaining access to data through the maintenance of composite records. points of departure have applied in this connection. One was that influence should be formulated taking into consideration respect for the patient's self-determination and privacy and that the care and processing should, as far as possible, be formulated and implemen- ted in consultation with the patient. The other point of departure was to find solutions that are practically flexible and easy to apply. They should not give rise to administrative burdens or other signifi- cant additional work in the course of the daily work of the health and care services' personnel. Applying these points of departure, the patient, already at the time of the relevant care regarding which a record is kept or when the data is otherwise documented (Phase 1), is afforded a right – after having been informed about what the maintenance of composite records means – to oppose care documentation relating to them being made available to other care providers. If the patient opposes the data being made available via the maintenance of composite records, access to the data shall be restricted for health and care per- sonnel and others at other care providers. Direct access may con- sequently not be gained to restricted data. However, this does not exclude data about a patient being disclosed to another care provider in exceptional cases. However, this issue does not involve data being made available through direct access in a system for the maintenance of composite records, but that data is disclosed in another way, for example, verbally; see proposal for Chapter 7, Section 1d, second paragraph of the Secrecy Act (1980:100). However, a system for the maintenance of composite records may contain information that there is restricted information. Such information may in individual care situations prompt appropriate dialogue between the patient and the physician or other care personnel. A restriction can be revoked at any time at the patient's request. The patient is also given the right to personally determine whether a care provider's health and care personnel should be per- mitted to use their access to get data from the care documentation of another care provider that is available in the composite records kept (Phase 2). This involves data that has not been restricted by the patient. Normally the patient's position regarding the matter will be ascertained in conjunction with the patient's initial contact with a new care provider. In order for a care provider at Phase 2 to be able to be afforded access to unrestricted data through the maintenance of composite records, it is necessary that the data may be assumed to be of signi- ficance for the care of the patient and that the patient consents to such access. If the patient's consent cannot be obtained, the data may be obtained through direct access if the data may be assumed to be of significance for the care that the patient necessarily needs. The fact that the patient's consent cannot be obtained may result from the patient being unconscious or in far too serious a condition to adopt a position on whether the care provider should be afforded access to the data. Furthermore, the matter may be so urgent that there is no time to obtain consent. A patient who opposes the care provider using direct access should always be respected. The maintenance of composite records may in principle not be used for purposes other than for individually oriented patient care. This means, for instance, that direct access to the data of other care providers may not be used for quality and other and financial follow-up of health and care services and re- search. To maintain the confidence of the public in the new system for the maintenance of composite records, it is important that cross- border direct access is only used for purposes and in situations that the individual can anticipate and have control over. In summary, the provisions on the maintenance of composite re- cords only regulate a certain way of making the patient records available electronically across formal organisational boundaries with- out preceding consideration of secrecy (see below) in each individual case when direct access is used. It can always be requested that the data is released in another way, in which connection the customary consideration of secrecy must be conducted. Personal data liability regarding the maintenance of composite records The general rules on personal data liability under the Act, providing that every authority within the health and care ser- vices or private care provider is the personal data controller for the processing of personal data that it conducts, will also apply regarding the maintenance of composite records. However, the Government may make regulations on personal data liability regarding the main- tenance of composite records on overall issues concerning technical and organisational security measures. Internal secrecy, etc. The right of health and care personnel to gain access to patient data Someone working at a care provider may, according to the Act, gain access to documented information about a patient only if they participate in the care of the patient or if they need the information for other reasons for their work within the health and care service. This provision comprises both manually and electronically produced patient records and other documentation about patients. The Act also prescribes that documented personal data should be handled and stored so that unauthorised parties – for example, officers within the health and care services who do not need the data for their work – are unable to gain access to it. 'Handled' and 'stored' refers to all kinds of measures that are imple- mented regarding personal data. Requirements regarding the maintenance of patient records and other electronic patient documentation As regards the maintenance of electronic patient records and other electronic patient documentation, the Patient contains a provision on electronic access that partially corresponds to the current rule in Section 8 of the Health Care Register Act, but which im- poses clearer requirements on the care provider as regards the authori- sation system, etc. The care provider should determine conditions regarding how personnel should be allocated authorisation for electro- nic access to data about patients within the care provider's operation. These rules mean that the allocation of authorisations by care pro- viders should be conducted on an and individualised basis following analysis of what further information various categories of personnel and various kinds of operation need. Special attention should be devoted to the accessibility of protected personal data. detailed provisions should be issued by the Government or the authority appointed by the Government. It is expected that will issue these regulations following consultation with . Obligation to document electronic access, etc. An obligation is also introduced for the care provider to document and check electronic access. By the care provider being liable to document all electronic access ('processing history' or 'log'), it will be possible to conduct retrospective checks. However, it is not sufficient to conduct follow-up checks in special cases where there may be a suspicion of unauthorised violation. Follow-up checks should be conducted systematically and on an ongoing basis. detailed provisions should be issued by the Government or the authority appointed by the Government. It is expected that will issue these regulations following consultation with . The patient's right to get information about access The individual patient is given the right to request to receive infor- mation about what direct access and electronic access has occurred regarding electronically processed data concerning them. de- tailed provisions on the information to be provided to the patient may be issued by the Government or the authority appointed by the Government. It is expected that will issue these regulations following consultation with . The patient's right to restrict accessibility Act affords the individual a right to request that the care documentation is restricted for electronic access from other care units, alternatively care processes, outside that to which the data belongs. Through this rule, the patient is provided with influence over access to data concerning them within a care provider's boundaries. This possibility should be regarded to be a result of the principle that health and care should be based on respect for the patient's self-determination and privacy and as far as possible should be performed and conducted in consultation with the patient. It should be possible for the restriction to be partially or completely lifted with the patient's consent, for example in a one-off care situa- tion. It should also be possible for the restriction to be overridden if the patient's consent cannot be obtained and provided the infor-