The NHS, Standards, Security & Identity Management

1. The NHS, Standards, Security & Identity Management Dr. Mark Ferrar Director of Infrastructure NHS Connecting for Health OASIS Adoption Forum – 28 November 2006

2. Agenda • NHS • NPfIT in context • Standards (used by NPfIT) • How do we use them? • How important are they? • Benefits & drawbacks • Security (of Information in NPfIT) • Overview • Standards • Identity Management • Standards • Challenges • Summary

3. NHS: NPfIT in context Setting the context for the National Programme for IT

4. Strategic objectives • To deliver a 21st century health service through efficient use of technology to: • Enable and improve Access and Choice • Enable care pathways and patient focus • Improve accuracy in treatment • Create opportunities for improved efficiency • Create opportunities for real NHS reform

5. Where’s your medical record kept?

6. Did someone take a back-up?

7. Scope for NHS Connecting for Health Secondary Uses Service chooseandbook Analysing National Health Trends Patient Choice • Largest civil IT project in the world • 40,000 GPs • 80,000 other doctors • 350,000 nurses • 300+ hospitals • 10 year programme • 50m+ patients • 1.344m healthcare workers Electronic Prescriptions Service North East N3 East West London Picture Archiving & Communications Service New National Network South NHSmail Healthspace Secure E-mail for all NHS workers Web Access for Patients National & Local Care Record Services

8. Architecture Overview

9. Integration Overview ICRS NASP Domain ( Security & Access ) PSIS PDS EPS ACF SDS SSB Secondary Care Application Event Engine/ Event Engine/ Security Integration Layer Integration Layer Infrastructure EPR EPR Primary Care Secondary Care Primary User Secondary User Application Application Enhanced Retained Legacy Systems HL7 V3 ebXML / HL7 V3

10. In a typical NHS week… • 6 million people visit their GP • Over 800,000 outpatients are treated • Over 10,000 babies are delivered by the NHS • Over 50,000 emergency journeys in NHS ambulances • District nurses make over 600,000 home visits • Pharmacists dispense ~8.5 million items • NHS surgeons performing ~1,200 hip operations, 3,000 heart operations and 1,050 kidney operations • Labs and associated services provide millions of tests results In other words, 3 million critical transactions each day!

11. National Programmes deliver… • 15,642 bookings a day through Choose & Book • 1.7 million bookings made so far in total • 7,605,966 prescriptions have been made electronically through ETP • 354,488 prescription messages in the last week • 16,053 (site) connections to the N3 network • 98% of GPs connected • 60 PACS installations from NHS CFH now live • 90,261,214 images have been stored from over 4,583,163 patient studies • 797,987 messages a day over NHSmail from 213,485 users (inc. NHS CFH) • 296,526 Smart Cards issued and in use • GP payments enabled by QMAS total over £1.7billion

12. And while we’re talking about scale… • 600,000 PC and 850,000 computer users in the NHS (in England) • NHSmail will have over 1.5 million users • World’s largest private, fully-featured, secure, single-domain e-mail service • NHSmail Relay Service processes 4,000,000 messages/day and activity bursts of 100 messages a second. • N3 network transacts almost 100 terabytes of data each month • That’s equivalent to the entire 32 volume set of the Encyclopaedia Britannica every 40 seconds • The processing power of the “Spine” and its test environments would put it in the top 100 supercomputers ever built • And it has over 300 terabytes of storage - equivalent to the contents of a book shelf 3000km long

13. For a typical week this results in…

14. Role & Importance of Standards The role and importance of Standards to the NPfIT

15. Standards and the National Programme • Standards adopted as a matter of… • Policy • e-GIF • NHS STEP – STandards Enforcement in Procurement • W3C/WAI • NHS Information Standards Board (“ISB”) • Preference • Contractual preference to support commercial flexibility • Need • Practical need in order to support inter-operability

16. ISB definition of an Information Standard "NHS Information Standards are information and communication technologies1, which achieve interoperability between independent computer systems [functional interoperability] and between independent users of data particularly patients, clinicians and managers [semantic interoperability] when using computer systems as part of NHS commissioned and provided care." Focus on safety, fitness for purpose, interoperability and implementation, ensuring both a specification and implementation guidance exist, meaning implementation is required before a standard is adopted or approved. 1 "Health Technology is an internationally recognised term covering any method used by those working in health services to promote health, prevent and treat disease and improve rehabilitation and long-term care. "Technologies" in this context are not confined to new drugs or pieces of sophisticated equipment." (http://www.hta.nhsweb.nhs.uk/FAQ/).

17. Examples of ISB Information Standards • Some examples of NHS Information Standards include: • Data standards such as datasets for national audits, statistics or commissioning • Message standards such as messages communicating patient allergy information between a GP system and the national ‘spine’ • Record content standards such as the ambulance service patient report form • Interface standards such as how date and time are displayed on the computer screen • Health related classifications and terminologies such as ICD-10 and SNOMED CT • Technical standards that facilitate communication and between systems and ensure effective operating, for example, network standards • Information governance standards: technical and behavioural standards that support safe, secure and confidential management of information.

18. Types & Stages of Standard • Types • Process manages each of three types with appropriate degrees of rigour. • An Operational standard is a detailed and precisely defined standard for operational use within a specific area of the NHS. The bulk of the standards considered by ISB are operational standards • A Fundamental standard is one which encompasses many distinct areas and will have multiple instantiations of operational standards • A Framework standard is an 'overarching' structure which can be employed to develop Operational and / or Fundamental standards • Stages • Three sequential stages, each ensuring that developer and sponsor provide evidence through testing that standard is needed, fit for purpose, can be implemented and integrated. • At Requirement standard stage, ISB assures a defined need within the NHS and that development and implementation plan is funded • At Draft standard stage, ISB assures early evidence of benefits delivery described in the 'Requirement' through testing • At Full standard stage, ISB assures evidence of ability to be implemented, interoperability and safety and is supported by a maintenance and update process

19. External Interface Specification (EIS) • Within the National Programme, interoperability and integration is specified in the EIS, which describes interfaces for the following national services: • Electronic Transfer of Prescriptions (ETP) • eBooking Service (EBS) • GP to GP (GP2GP) - EHR transfer service • Gazetteer Service • Spine Directory Service (SDS) • Spine Security Broker (SSB) • Personal Demographics Service (PDS) • Legitimate Relationship Service (LRS) • Personal Spine Information Services (PSIS) • Also provides protocol and message format standard for the exchange of HL7/XML messages between a service client and a national service.

20. EIS references various standards • Adopts standards from various consortia as defined in their respective formal definitions. • Implementers should1always refer to the standards for detailed guidance. • Where conflicts exist between specification and standard, the standard takes precedence. • The following key standards have been adopted: • HL7 Version 3. • XML family of standards, W3C. • OASIS ebXML Message Services Specification. • OASIS ebXML Collaboration-Protocol Profile and Agreement Specification. • SOAP, W3C Recommendation. • HTTP, IETF RFC. • XML-Signature, W3C Recommendation. • LDAP, IETF RFC. • Assertions and Protocol for OASIS Security Assertions Markup Language (SAML v1.1). • (1) The keywords MUST, MAY, RECOMMENDED, and SHOULD are to be interpreted as described in RFC2119

21. EIS relates to NASP & LSP services • EIS describes external interfaces from a technical perspective. • Targeted at architects, designers and builders responsible for delivery of Local Service Provider (LSP) systems, national service systems and the ICRS Spine. • Assumes familiarity with: • HL7 • XML • ebXML • XML Security • SOAP • HTTP • LDAP • Single Sign-on (SSO) • SAML • UML

22. EIS References

23. Other standards adopted by NPfIT • NPfIT also relies on various other international standards not described by (or relevant to) the EIS, but just as important • Medical Terminology • SNOMED-CT • Various other infrastructure standards (not already mentioned) • TCP/IP v4 • DNS • TLS / SSL • X.509 • IEEE 802.3 • IEEE 802.11 • 3DES • AES • RC4 • IMAP • Etc… • In fact, standards of one sort or another pervade most elements of the programme.

24. Standards we’re developing ourselves • HL7 NHS Extensions • Being adopted into mainstream HL7 • Common User Interface (CUI) • Design Guide for components of the clinical UI • Licensed for use outside the NHS • Collaborative development via Participation Agreement • Focus on Patient Safety & Clinical Efficiency • Independent of application development environment or language • Some taken through the NHS ISB processes • Toolkit • Implementation of DG in Microsoft .NET v2 • (Desktop & Infrastructure) • (Office)

25. Benefits & Drawbacks of Standards Benefits and drawbacks to using standards

26. Benefits • Interoperability • End to end service delivered using different brands and products • Service delivered using different versions of same products in different parts of the organisation • Service interoperates with other organisation’s services (that use same or compatible standards or interfaces) • Longevity • Protection against innovation obsolescence when combined with SOA • Commercial firms “innovate” to improve product (fix bugs, enhance performance) AND generate steady revenues (make users upgrade) • A long term (10 year) programme must manage product innovation alongside long term sustained service delivery and stability. • Flexibility • Add or delete a product from the service mix • Add or delete a service • Avoiding vendor lock-in • Avoid Service Provider lock-in • Extend organisation or enterprise (integrate 3rd party business services)

27. Benefits Thanks to Patrick Gannon for the following reference: US DoD Open Technology Development, A Roadmap Plan, April 2006 “As software becomes increasingly networked, design and engineering methodologies have evolved towards services-based architectures that communicate through open and standardized interfaces. Often, these services and interfaces are provided with OSS reference implementations. Once this type of open, service based architecture is implemented, the system naturally decomposes into a modular design ― each service is free to improve and evolve independently as long as it communicates through the standard interfaces.” http://www.acq.osd.mil/asc/ But this should apply equally to proprietary systems built to comply with open standard interfaces – each service is free to improve and evolve independently so long as the interface standard remains stable and is adhered to.

28. Drawbacks • Implementation variation • Proprietary implementations of the “standard” may fail to interoperate • Heavily customised implementations of complex applications built on equally complex standards become bespoke (almost proprietary) solutions • E.g. Java engine variations • E.g. smart card “standards” • Implementation quality • E.g. Bluetooth used in Assistive Technology / Telecare / Telemedicine • Performance disadvantage against “tuned” proprietary solutions • E.g. IMAP clients versus proprietary e-mail client / server protocols • Obsolescence when the standard changes • E.g. SAML v1.1 versus SAML v2.0 • Competing Standards • That’s the thing about standards, there are always so many to choose from • E.g. ebXML business process and modelling standards overlap with HL7 standards specific to healthcare – which should the NHS choose to implement?

29. Security Architecture of NPfIT Security Architecture of the National Programme

30. Key security challenges • How do you ensure only those who need access gain access to any one of 50 million patient records? • How do you provide single sign-on with >10 service providers, >50 applications and 12,000 separate NOS installations? • How do you provide e-GIF Level 3 2-factor authentication with 30% of your users outside your organisation and network?

31. From patient and clinician perspectives I need secure access to clinical systems and patient information How can I be sure that people who do have a need to access my medical record only get access to what they need? Who’s been accessing my record? I need a single way of proving my identity to all systems that I use Can I be sure people who have no need to see my medical record will not be able to see it?

32. Our Data Protection Act obligations • DPA defines much of the data held on NCRS systems as “sensitive personal data” • We have a duty of care to protect data appropriately • Government guidelines say the release of “personally … sensitive data to third parties” requires Registration at Level 3, via which “the registrant’s real world identity is verified beyond reasonable doubt” • Guidelines also say Registration at Level 3 should be combined with Authentication at the same level

33. NCRS security components overview

34. Role Based Access Control “Can I be sure that people who do have a need to access my medical records only get access to what they need?”

35. Why Role Based Access Control? • Well understood approach with proven success in large business systems • The NHS is a business with complex role-to-task and task-to-business process mapping • Most existing health applications incorporate some form of Role Based Access Control

36. Roles Based Access Control model xxxx xxxx xxxx xxxx xxxx CFH Applications Healthcare Professional Activity/ Business Function(s) Organisation(s) Job Role(s) National Care Records Service (NCRS) Choose and Book (CAB) Electronic Transmission of Prescriptions (ETP) Secondary Uses Service (SUS) Etc. Etc.

37. However, RBAC alone is not enough… • The functions people perform can cross job boundaries • Some functions are available only to certain users in a particular job • Some functions are not related to a user’s “day job” at all • Different NHS organisations have different ideas about what someone in a particular role can do

38. Enhancements to RBAC are needed • Transparent to the choice of service provider supporting the real world “things” people do. • Uses the role concept for the majority of rights a user has, so that Registration Authorities are not faced with the individual nomination of every separate detailed access right. • Provides the flexibility needed to support policy change. • Permits policy variation across the NHS, controlled in a manner that preserves a common understanding of Job Roles and the rights they carry.

39. Legitimate Relationships “Can I be sure that people who have no need to see my medical record will not be able to see it?”

40. What is a Legitimate Relationship? • The Legitimate Relationship Service (LRS) enables systems to verify a permitted relationship exists between the system user and the patient before allowing access to requested data • A user cannot access a patient's clinical record without a Legitimate Relationship (LR) • Many different types of LR, but almost all are invisible to the user and are triggered by patient-related events • Legitimate Relationships have lifecycles (they can expire) • Creating Workgroups and assigning users to them is a vital function for NHS organisations and to the LRS

41. LR Workgroups – how they work Patient has LR with the Workgroup, e.g. all GPs in a given Surgery – established when a patient registers with a GP Clinician (User) is member of the Workgroup WG Clinician (User) permitted access to patient record as valid LR exists via the Workgroup to patient Additionally, there can be direct LRs between individual User Role Profiles (clinicians) and Patients – these are ‘Self-claimed’ and ‘Colleague-granted’ LRs – e.g. in A&E.

42. Sealed Envelopes “Can I be sure that people who see my record will not be able to see particularly sensitive medical details which I want to keep secret only to myself and any specialists treating me?”

43. What is a Sealed Envelope? • Patients will be able to select parts of their record to which they wish access to be restricted • They can require that only nominated people can see these parts • This can be overridden (with an alert) if the patient’s life is in danger and the patient cannot be asked • Clinicians will also be able to seal off parts of the record from the patient (e.g. where knowledge by the patient may lead them to harm themselves or others).

44. Authentication “How do I know who has access to my medical records?”

45. NHS Smartcards • A secure “Chip and Pin” card to hold a user’s unique identity (digital certificates) • Supports 2 factor authentication required by e-GIF Level 3: • Something you have (the Smartcard) • Something you know (the Passcode) • Passcode only stored on the card • Certificate is validated to ensure currency as the user authenticates • Any magnetic strip on the card is not used for authentication or to hold digital signatures • Future support for biometrics and proximity

46. 3-step registration process Present Documents Spine Directory Service Register User CMS CMS SUD Card Management System User Registered Smart Card Assigned Smart Card Created Smart Card Issued Sponsor User CA Agent • 3 - Smartcard issue from Card Management System (CMS) • Import person from SUD • Take clear image of applicant with Webcam • Print and issue the card • Test the card • 1 - Validation of application to register • Complete an application form (RA01) • Have identity vouched for by sponsor or present suitable documentary evidence of identity • Obtain sponsorship for appropriate job profile • 2 - Registration into the Spine User Directory (SUD), a sub-component of the Spine Directory Service (SDS) • Search for user and ensure no duplicates created • Create a basic user profile • Associate with organisation(s) • Assign correct role(s)

47. The user login experience Insert SmartCard into Card Reader Authentication Confirmed Set Session Role Start Relevant User Application Enter Passcode

48. Logon “behind the scenes” • User inserts smart card or attempts access to a protected resource. • Identity Agent (IA) prompts User for (smart card and) Passcode. • Spine Security Broker (SSB) Service validates credentials and, if successful, establishes a Session. • SSB creates Single Sign-On (SSO) Token that includes: • Unique User ID (UID) • Token ID • Session attributes, e.g. max_idle_time • Also creates Attribute Assertion including: • Name, UID, OCS Code, Default Role, Job Role(s), Organisation(s), Business Function(s), Area of work(s), Workgroup(s) • SSB also establishes a Token • ID passed to IA, stored in memory on User’s PC and points to SSO Token held in ID Server. • User starts application. • Application obtains Token ID from IA • Application checks validity of token with ID Server. • Applications can also retrieve session information using the Token ID to get SSO Token values. • Application Access control Decision Function (ADF) gets/parses SAML Assertion for attributes • Application ADF processes User requests in its own context based on user information in SSO Token and Assertion.

49. Logging & auditing • Access to records & actions performed are logged against an individual’s identity (via their smart card ID), not against the Workgroup (which enables the RBAC) • Claiming of a LR (or attempting access without a LR) generates an alert • Alerts are dealt with by Caldicott Guardians – an existing role within the NHS – the safeguards of patient confidentiality • Access logs are kept as long as the EMR

50. The Identity Management Challenge The Identity Management Challenge