ISO TR 11633-1-2009 Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1 Requ.pdf

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1、 Reference number ISO/TR 11633-1:2009(E) ISO 2009TECHNICAL REPORT ISO/TR 11633-1 First edition 2009-11-15 Health informatics Information security management for remote maintenance of medical devices and medical information systems Part 1: Requirements and risk analysis Informatique de sant Managemen

2、t de la scurit de linformation pour la maintenance distance des dispositifs mdicaux et des systmes dinformation mdicale Partie 1: Exigences et analyse du risque ISO/TR 11633-1:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file m

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7、 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedISO/TR 11633-1:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Terms and definitions .1 3 Abbreviated terms.3 4 An outline o

8、f remote maintenance services security3 4.1 Contents of remote maintenance services security3 4.2 Security requirement of remote maintenance services 5 4.3 Roles of remote service centre and healthcare organization.6 5 Use case of remote maintenance services.7 5.1 Introduction7 5.2 Trouble shooting

9、for outages 8 5.3 Scheduled maintenance .9 5.4 Software updating .10 6 Risk analysis11 6.1 General .11 6.2 Risk analysis criteria.11 Annex A (informative) Example of risk analysis result of remote maintenance services.12 Bibliography17 ISO/TR 11633-1:2009(E) iv ISO 2009 All rights reservedForeword I

10、SO (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 member body interested in a subject for which a technical c

11、ommittee 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 International Electrotechnical Commission (IEC) on all matters of electr

12、otechnical 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 adopted by the technical committees are circulated to the m

13、ember 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 that which is normally published as an International Standard

14、 (“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 provides are considered to be no longer valid or useful. Att

15、ention 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 11633-1 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO/TR 11633 consists

16、 of the following parts, under the general title Health informatics Information security management for remote maintenance of medical devices and medical information systems: Part 1: Requirements and risk analysis Part 2: Implementation of an information security management system (ISMS) ISO/TR 1163

17、3-1:2009(E) ISO 2009 All rights reserved vIntroduction Progress and spread of technology in information and communication fields and well-arranged infrastructure based on them have brought various changes into modern society. In the healthcare field, information systems formerly closed in each healt

18、hcare facility are now connected by networks, and they are coming to the point of being able to facilitate mutual use of health information accumulated in each information system. Such information and communication networks are spreading, not only amongst healthcare facilities but also amongst healt

19、hcare facilities and vendors of medical devices or healthcare information systems. By practicing so-called “remote maintenance services” (RMS), it becomes possible to reduce down-time and lower costs. However, such connections with external organizations have come to bring healthcare facilities and

20、vendors not only benefits but also risks regarding confidentiality, integrity and availability of information and systems, risks which previously received scant consideration. Based on the information offered by this part of ISO/TR 11633, healthcare facilities and RMS providers will be able to perfo

21、rm the following activities: clarify risks originating from using the RMS, where environmental conditions of the requesting vendor site (RSC) and maintenance target healthcare facility site (HCF) can be selected from the catalogue in Annex A; grasp the essentials of selecting and implementing both t

22、echnical and non-technical “controls” to be applied in their own facility against the risks described in this part of ISO/TR 11633; request concrete countermeasures from business partners, as this document can identify the relevant security risks; clarify the boundary of responsibility between the h

23、ealthcare facility owner and the RMS provider; plan a programme for risk retention or transfer as residual risks are clarified when selecting the appropriate “controls”. By implementing the risk assessment and employing “controls” referencing this part of ISO/TR 11633, healthcare facilities owners a

24、nd RMS providers will be able to obtain the following benefits: it will only be necessary to do the risk assessment for those organizational areas where this part of ISO/TR 11633 is not applicable, therefore, the risk assessment effort can be significantly reduced; it will be easy to show the validi

25、ty of the RMS security countermeasures to a third party; if providing RMS to two or more sites, the provider can apply countermeasures consistently and efficiently. TECHNICAL REPORT ISO/TR 11633-1:2009(E) ISO 2009 All rights reserved 1Health informatics Information security management for remote mai

26、ntenance of medical devices and medical information systems Part 1: Requirements and risk analysis 1 Scope This part of ISO/TR 11633 focuses on remote maintenance services (RMS) for information systems in healthcare facilities as provided by vendors of medical devices or health information systems (

27、RMS providers) and shows an example of carrying out a risk analysis in order to protect both sides information assets (primarily the information system itself and personal health data) in a safe and efficient (i.e. economical) manner. This part of ISO/TR 11633 consists of: a catalogue of use cases f

28、or RMS; a catalogue of information assets in healthcare facilities (HCF) and RMS providers; an example of the risk analysis based on use cases. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 accountability property that ensures that the acti

29、ons of an entity may be traced uniquely to the entity ISO/IEC 13335-1:2004, definition 2.1 2.2 asset anything that is of value to the organization NOTE 1 Adapted from ISO/IEC 13335-1. NOTE 2 In the context of health information security, information assets include: a) health information; b) IT servi

30、ces; c) hardware; d) software; e) communication facilities; f) media; g) IT facilities; h) medical devices that record or report data. ISO/TR 11633-1:2009(E) 2 ISO 2009 All rights reserved2.3 assurance result of a set of compliance processes through which an organization achieves confidence in the s

31、tatus of its information security management 2.4 availability property of being accessible and usable upon demand by an authorized entity ISO/IEC 13335-1:2004, definition 2.4 2.5 compliance assessment processes by which an organization confirms that the information security controls put in place rem

32、ain both operational and effective NOTE Legal compliance relates specifically to the security controls put in place to deliver the requirements of relevant legislation such as the European Union Directive on the protection of personal data. 2.6 confidentiality property that information is not made a

33、vailable or disclosed to unauthorized individuals, entities or processes ISO/IEC 13335-1:2004, definition 2.6 2.7 data integrity property that data have not been altered or destroyed in an unauthorized manner ISO/IEC 9797-1:1999, definition 3.1.1 2.8 information governance processes by which an orga

34、nization obtains assurance that the risks to its information, and thereby the operational capabilities and integrity of the organization, are effectively identified and managed 2.9 information security preservation of confidentiality, integrity and availability of information NOTE Other properties,

35、particularly accountability of users, but also authenticity, non-repudiation, and reliability, are often mentioned as aspects of information security, but could be considered as derived from the three core properties in the definition. 2.10 risk combination of the probability of an event and its con

36、sequence ISO/IEC Guide 73:2002, definition 3.1.1 2.11 risk assessment overall process of risk analysis and risk evaluation ISO/IEC Guide 73:2002, definition 3.3.1 2.12 risk management coordinated activities to direct and control an organization with regard to risk NOTE Risk management typically incl

37、udes risk assessment, risk treatment, risk acceptance and risk communication. ISO/IEC Guide 73:2002, definition 3.1.7 ISO/TR 11633-1:2009(E) ISO 2009 All rights reserved 32.13 risk treatment process of selection and implementation of measures to modify (typically reduce) risk NOTE Adapted from ISO/I

38、EC Guide 73:2002. 2.14 system integrity property that a system performs its intended function in an unimpaired manner, free from deliberate or accidental unauthorized manipulation of the system 2.15 threat potential cause of an unwanted incident, which may result in harm to a system or organization

39、NOTE Adapted from ISO/IEC 13335-1. 2.16 vulnerability weakness of an asset or group of assets that can be exploited by a threat NOTE Adapted from ISO/IEC 13335-1. 3 Abbreviated terms HCF Healthcare facility ISP Information-stealing programme PHI Personal health information RMS Remote maintenance ser

40、vices RSC Remote maintenance service centre RSS Remote maintenance service security VPN Virtual private network 4 An outline of remote maintenance services security 4.1 Contents of remote maintenance services security 4.1.1 General Remote maintenance services (RMS) have three main purposes: response

41、 at the time of medical equipment malfunction; routine maintenance; updating of the software. ISO/TR 11633-1:2009(E) 4 ISO 2009 All rights reservedIn this part of ISO/TR 11633, a system which consists of target devices and an internal network within healthcare facilities (HCF) site, an external netw

42、ork connecting HCF and remote maintenance service centre (RSC), and an internal network and equipments or services within RSC is assumed. See Figure 1. This part of ISO/TR 11633 introduces the styles of the RMS that each RMS provider provides and the current state of the security measures. RSC inter

43、nal network HCF (b) internal network HCF (a) internal network RSC services RSC equipment RSC access point External network HCF (b) access point Ta r g e t systems Target devices Target systems Target devices HCF (a) access pointFigure 1 Assumed remote maintenance services 4.1.2 Styles of remote main

44、tenance services and technical security measures 4.1.2.1 Remote maintenance services using a public switched telephone network HCF sets up a machine for dial-up server function. This machine connects with a public switched telephone network by modem, etc., and waits for access from RSC remote equipm

45、ent. Telecommunications equipment that offers all functions such as dial-up routers are in widespread use. In the use of the public switched telephone network, telecommunication lines have the following features: a one-to-one communication pathway between HCF and RSC can be secured; tapping is diffi

46、cult because a public switched telephone network is fully-digitalized. Using these features, security is maintained by the following technical measures: a) determination of caller number use of call back certification function or caller ID specification certification function; b) user certification

47、use of one-time password and encryption of password; c) review of communication audit log detection of illegal access to a computer. ISO/TR 11633-1:2009(E) ISO 2009 All rights reserved 54.1.2.2 Remote maintenance services using the Internet A device for internet connection with fixed global IP addre

48、ss is placed on the HCF. The RSC prepares the Internet connection environment and connects itself to HCF through the Internet. This part of ISO/TR 11633 specifies more technologies for communication and user authentication between HCF and RSC, because this is the same as a typical Internet connectio

49、n and not a one-to-one communication like the public switched telephone network. This part of ISO/TR 11633 illustrates the following examples: a) erecting a fire-wall; b) using tools such as anti-virus software; c) communication using VPN for encryption of the communication path; d) use of a variety of user authentication methods such as one-time passwords, password encryption and use of digital certificates. 4.2 Security requirement of remote maintenanc