1、 Reference number ISO/TR 21548:2010(E) ISO 2010TECHNICAL REPORT ISO/TR 21548 First edition 2010-02-01 Health informatics Security requirements for archiving of electronic health records Guidelines Informatique de sant Exigences de scurit pour larchivage des dossiers de sant lectroniques Lignes direc
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6、r ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedISO/TR 21548:2010(E) ISO
7、 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Terms and definitions .1 3 Abbreviated terms .1 4 eArchive and eArchiving process .2 4.1 eArchive2 4.2 eArchiving process .2 4.3 Backup and recovery 4 5 Environment of the eArchive .4 6 Responsibilities and policies .5
8、6.1 General .5 6.2 Responsibilities .5 6.3 Policies .7 7 Design and implementation of secure eArchiving process for EHRs .9 7.1 General discussion .9 7.2 Analysis of the business model.10 7.3 Identification of impact of ethical and legal requirements11 7.4 Risk analysis of existing systems and the d
9、eveloped system.11 8 Implementation of security requirements.12 9 Security and privacy protection controls and instruments for archiving of EHRs 14 9.1 Tasks of the eArchive .14 9.2 Tasks of EHR system15 9.3 Selection of security instruments16 9.4 Privacy protection instruments .17 9.5 Audit-log.17
10、9.6 Security instruments.17 9.7 Administrative instruments22 9.8 Metadata .22 9.9 Registration service 25 9.10 Destroying of records .25 9.11 Managing the security of EHRs with dynamic content .25 10 Education and training25 Annex A (informative) Summary of additional guidelines 26 Bibliography30 IS
11、O/TR 21548:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each
12、 member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Internationa
13、l Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards
14、 adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from t
15、hat which is normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it
16、provides are considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 21548 was prepared by Technical Commi
17、ttee ISO/TC 215, Health informatics. ISO/TR 21548:2010(E) ISO 2010 All rights reserved vIntroduction This Technical Report is an informative report that provides additional guidance for implementation of requirements set by ISO/TS 21547. This Technical Report provides a guideline and method to selec
18、t (from the requirements defined by ISO/TS 21547) a platform or domain-specific set of requirements fulfilling regulatory and normative requirements. The platform can be local, regional, national or cross-border. This Technical Report is planned to be used together with ISO/TS 21547. This Technical
19、Report provides guidelines that are intended as a supplement to ISO/TS 21547. The summary of additional guidelines is shown in the Annex A. This Technical Report defines a practical method and describes practical tools which can be used both in the development and management of eArchives fulfilling
20、security requirements set by ISO/TS 21547. Most of those tools are not healthcare specific, but the selection and the implementation of security services and tools should always meet general and healthcare domain- specific requirements set by national legislation, norms and ethical codes. TECHNICAL
21、REPORT ISO/TR 21548:2010(E) ISO 2010 All rights reserved 1Health informatics Security requirements for archiving of electronic health records Guidelines 1 Scope This Technical Report is an implementation guide for ISO/TS 21547. This Technical Report will provide a methodology that will facilitate th
22、e implementation of ISO/TS 21547 in all organizations that have the responsibility to securely archive electronic health records for the long term. This Technical Report gives an overview of processes and factors to consider in organizations wishing to fulfil requirements set by ISO/TS 21547. 2 Term
23、s and definitions For purposes of this document, the terms and definitions listed in ISO/TS 21547 apply. 3 Abbreviated terms CDA Clinical documentation architecture EHR Electronic health record GP General practitioner HIS Hospital information system HL7 Health level 7 ISMS Information security manag
24、ement system PKI Public Key Infrastructure LAN Local area network PACS Picture Archiving and Communication System TTP Trusted Third Party XML Extensible Mark-up Language VPN Virtual Private Network ISO/TR 21548:2010(E) 2 ISO 2010 All rights reserved4 eArchive and eArchiving process 4.1 eArchive In h
25、ealthcare an archive is defined as being an organization that intends to preserve health records for access and use for an identified group of consumers for a regulated period of time. An electronic archive (eArchive) preserves information in digital format. An eArchive has the responsibility of mak
26、ing information available in a correct and independently understandable form over a long period of time. To make this possible, the eArchive stores not only the data but also meta-information (e.g. representation, description, content and context information of the data, links between components and
27、 required preservation information). Typically, an eArchive receives and stores fixed content of data (e.g. EHRs or parts of them) with associated metadata and policies. An alternative is to use the weeding method the EHR system moves selected EHRs to a secondary storage area of the EHR system and s
28、tores the needed meta-information (including security rules) in a separate repository. A typical method of storing fixed content of data is to preserve documents with associated metadata such as HL7, CDA or XML documents. Digital archiving has a strong dependence on software. New file formats, softw
29、are and platforms succeed each other rapidly and digital material requires constant maintenance in order to retain accuracy. An eArchive can be a centralized organization or it can be federated (ISO/TS 21547:, 6.2). In healthcare, the narrative patient record and images are typically archived separa
30、tely (for example X-ray pictures are preserved by dedicated PACS-systems or by a RIS, ECGs and other bio-signals by their own dedicated systems). The eArchive can serve only one dedicated user (e.g. one hospital or GP) in such a way that only health records created by this organization are preserved
31、. On the other hand, one technical eArchive can store health records on behalf of many EHR systems. The federated eArchive can store records having the same security and preservation policy or it can preserve records having different security policies. In the latter case, the eArchive can be seen te
32、chnically as one archive, but from a security point of view it includes many logical EHR-archives. In practice, an eArchive can be a separate archive (“a secondary storage”) or an EHR system can manage all archiving functions without a separate technical eArchive. In the latter case the EHR system s
33、hould meet security requirements set by national legislation and principles and requirements defined in ISO/TS 21547. 4.2 eArchiving process ISO/TS 21547 has already defined that eArchiving is a holistic and long-term process. During this process, health records are moved between the EHR systems and
34、 the eArchive (the eArchive itself can be an external repository or a place in the EHR system where fixed records are stored). Figure 1 shows one practical model, where information is extracted from the local EHR-system database and transferred (in the form of documents) to the eArchive. The eArchiv
35、e can also disclose preserved documents, which can be either viewed by end users or restored to the local database. ISO/TR 21548:2010(E) ISO 2010 All rights reserved 3EHR Metadata BODY EHR eArchive BODY Metadata Data viewer Extract Semantic mapping or parsing Restoring Relational DB Destroying Figur
36、e 1 Example of the eArchiving process A typical eArchiving process consists of the following phases. The archiving process starts when information is extracted from the EHR-database. The next step is to make (if necessary) semantic mappings between local terminology and terminology used for the long
37、 term archiving (e.g. to maintain semantic interoperability). The third phase in this process is the generation of the archival packet (e.g. data and its metadata), which is sent to the eArchive. The eArchive stores received information in a fixed format for a defined period of time. The eArchive se
38、nds the requested information packets back to the EHR system, typically in the same format as that in which the information has been received. The eArchive can also destroy records. At the level of an EHR system the information can be either restored to the local database or viewed by the end user w
39、ithout restoration. If it is necessary to maintain semantic interoperability, the EHR system information will parse received information before it is restored. Countries differ in their definition of the eArchiving process: it can cover the whole lifecycle of the EHR or only a part of it. In Finland
40、 (ISO/TS 21547:, Annex A) the eArchiving process starts when patient information is initially created by the service provider and ends after the destruction of the record. In this case the service provider organization should manage the whole eArchiving process. In the UK (ISO/TS 21547: Annex B), ar
41、chives are records appraised for permanent preservation and the term archiving is used to describe permanent preservation of records in the Place of Deposit. Because the patient documents are dynamic during the care process, the information provider (typically a patient information system or Hospita
42、l Information System) transfers patient documents to the eArchive for long-term preservation at the time when the care process is ended and the patients documents have been signed by the responsible clinician(s). It is not always easy to define exactly the time when the care process is ended. In the
43、 case of hospital inpatient care this is typically the discharge time. Outpatient care, prevention and rehabilitation do not, in many cases, have a well-defined end point. Therefore, healthcare service organizations should define a minimum period after which the records of non-active patients should
44、 be extracted for long-term archiving. This period can also be defined by national legislation. ISO/TR 21548:2010(E) 4 ISO 2010 All rights reservedISO/TS 21547 has defined the eArchiving process as including the following security services: security services when data are captured from the EHR syste
45、m to the form defined and accepted by the eArchive; creation of security information (security metadata) connected to the record or data objects, and the linkage of this information to the data; security services needed to create the access request to the archive; security services needed during the
46、 data transfer from the EHR system to the eArchive and vice versa; security services needed by the eArchive to create a secure archival “packet” for long-term preservation; security services during the preservation period and in the event of data disclosure; security services needed to view and rest
47、ore disclosed data; security services needed to prove the non-repudiation of the eArchiving process. Data can be transferred from the EHR system to the eArchive using different technologies. One method is to send health records to the archive in the form of digital documents (for example in the form
48、 of XML or a HL7CDA document). Another possibility is to use the EN 13606 extract model or HL7 R3 messages to move information to the eArchive. It is outside the scope of this Technical Report to comment on specific technology in use. The whole eArchiving process should be documented. This documenta
49、tion should describe all participants and their roles and responsibilities (ISO 15489-1:2001, 9.10). Typical participants in the eArchiving process are: health service providers, telecommunication operators, the eArchive, and customers as patients and citizens. 4.3 Backup and recovery The backup system is a method of copying electronic records to prevent loss through system failures (ISO/TR 15489-2). The backup includes multiple copies of records and dispersed storage locations for backup
