Standards are relevant to every aspect of our daily lives, from the way we drive to the food we eat. International standards are especially important. Consider the Automatic Teller Machine (ATM): people can use a personalized card to obtain money almost anywhere in the world because the banking systems have all adopted relevant international standards. In contrast, when travelling abroad, people have to carry an adaptor plug because different countries do not have the same standard for electricity power points. This chapter uses ISO 690, the international standard for bibliographic referencing, which is embedded in the word processing software.

Aside from personal convenience, international standards benefit us in numerous ways. They:

ISO defines a standard as:

A document established by consensus and approved by a recognized body that provides for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. [2]

Put more simply, a standard is ‘an agreed way of doing something’ [3]

Both of these definitions conform to international standards for formulating good definitions [4] in that they state what the concept is without using the word that is being defined. The second definition conforms very well in that it is concise, unambiguous and states the essential meaning of the concept. The first definition includes a purpose (‘..aimed at the achievement of …’) which goes against the recommendation that a good definition should ‘be expressed without embedding rationale, functional usage, domain information, or procedural information’ [4; p7]. However, in order to understand HI standards we need to consider both their purpose and their ‘functional usage’, particularly conformance assessment.

Before discussing these topics however, there is one other aspect of the definition of a standard that needs to be considered, most easily understood as the difference between a noun and an adjective. ISO sees a standard as a document but people often refer to things as standards, for example: ‘the Braden scale is the standard assessment tool for pressure ulcer risk in our organization’; ‘we use a standard terminology in our electronic record system’; ‘the X monitor is the standard device for measuring blood pressure in neonates’. In these examples, the Braden scale, the terminology and the device have been adopted by a clinical team, an organization or other body as their standard approach. In order to ensure quality and consistency, staff would be expected to use only these artefacts in the situations for which they have been adopted.

This meaning of the word ‘standard’ (i.e. as a descriptor that gives an artefact additional status) is not covered further in this chapter – here we focus on standards as documents that state ‘rules, guidelines or characteristics’. Interestingly, many standards support the selection of artefacts for preferred use by describing the characteristics that make them safe, effective and useful. For example: ISO 9919 is a family of standards that specify the characteristics of medical electrical equipment such as pulse oximeters so that these can be assessed for safety and performance; ISO/TS 17117 sets out the essential features of controlled health terminologies to support evaluation as well as development. Supporting safety and evaluation are just two of the purposes of HI standards summarised below.

At a general level, HI standards support clinical practice and the management, delivery, and evaluation of health services [5]. According to ISO, their specific purpose is ‘to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of effort and redundancies’ [6].

Interoperability is ‘the ability of two or more systems or components to exchange information and to use the information that has been exchanged’ [7]. Expanding on this definition, Health Level Seven International (HL7), a standards development organization (SDO), talks about functional and semantic interoperability:

In all healthcare settings across the globe, we need to be able to exchange information reliably and then interpret and use it effectively: interoperability is essential. Reducing duplication of effort and redundancy are also important goals, as are making manufacture, supply and trade easier. However, there is something missing from this list of purposes for HI standards and that is the safe, effective integration of information management and ICT into clinical practice. This purpose fits well with definitions of nursing informatics which emphasise the integration of the science and art of nursing with information management and ICT [9]. This leads to the conclusion that HI standards have two main purposes: to support interoperability and to guide safe, effective HI practice. However, it is their ‘functional usage’ which is perhaps most important – we use standards to guide what we do and to measure conformance, discussed next.

In the same way that we use practice standards to audit the quality of nursing care, we use HI standards to ensure that HI systems and the way we use them conform to agreed ‘best practice’. The word ‘conform’ is key: a standard is something against which conformance or compliance can be measured – see Table 7.1 for definitions of conformance and compliance. In the two definitions above, I was able to evaluate the degree to which the definitions conform to the statements in the ISO standard for the formulation of data definitions [4].

A good test of the quality of a standard is whether it is specified in a way that makes assessment of conformance possible. Consider the two statements below related to on-screen display of medication:

Imagine the process of evaluating a new medication administration system before it is introduced in the hospital. A subjective assessment is necessary against Statement 1 above, but Statement 2 allows for an objective and replicable measurement i.e. either there is ‘one blank, non-breaking space’ etc. or there is not.

Closely related to conformance is the idea of ‘levels of mandation’ – a term that groups the categories of ‘mandatory’, ‘conditional’ and ‘optional’. Mandatory statements in a standard are those that must be complied with. Conditional ones must be complied with if certain specified conditions are met and optional ones are recommended but not required for conformance (ISO/IEC 11179–3). These terms are explained further in Table 7.1 but an example is given below from the End of Life Care Co–ordination Information Standard published by the English National Health Service (NHS) [11].

This standard specifies the required format for core content of the record to communicate a person’s end of life care decisions and preferences. One of the requirements in the standard is that Clinical governance and IT safety leads in each organization where the standard is implemented MUST ensure that the editing rights for specified clinical content elements are limited to the appropriate clinicians. This mandatory (MUST) requirement aims to ensure that only the lead clinician records or amends critical information such as Do Not Attempt Resuscitation orders. Some content elements such as demographic details are mandatory in every record. Others should be recorded once the person has made a decision (conditional), for example, ‘Preferred place of death’.

There are some similarities between these levels of mandation and the way we talk about professional standards. In health care, we terms like ‘requirements’, ‘recommendations’ and ‘principles’ which are found in Regulations, Clinical Guidelines and Practice Guidance. Regulations are legal or professional requirements for practising nurses mainly aimed at protecting the public. In the US, education and licensure requirements are set by the State Boards of Nursing [12] and a Code of Ethics for Nurses is published by the American Nurses Association [13]. In the UK, the Nursing and Midwifery Council is the regulatory body established in law that sets standards for education, conduct, performance and ethics [14].

In contrast, clinical guidelines are ‘Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances’ [15; p38]. ‘Systematically developed’ means that a systematic literature search and review of research evidence have been undertaken using agreed criteria and rigor. Practice guidance is generally evidence based but has not been systematically developed, depending rather on consensus among practice experts. The terms guideline, guidance, practice standard, practice parameter, quality standard and others are frequently used interchangeably. They are all standards in that they are ‘agreed ways of doing something’. No matter what they are called, the important thing is to know how they were developed and who approved or endorsed them so that users can decide whether to comply with the recommendations made.

All nurses must comply with Regulations if they are to continue to practise. However, the degree to which a nurse is expected to comply with clinical guidelines or practice guidance will depend on national and local polices but often comes down to (a) the strength of the evidence that supports the recommendations and (b) the authority of the organization that has published or adopted the standard.

Continuing the example of End of Life Care, all clinicians would be expected to comply with the End of Life Care Quality Standard published by the English National Institute for Health and Clinical Excellence (NICE) [16]. NICE has the same kind of authority as the US Agency for Healthcare Research and Quality (AHRQ) [17] – clinicians would have to give a very good reason for not complying with guidelines from these organizations, for example, in a court of law or fitness-to-practise hearing.

Standards produced by less well known organizations can be equally authoritative provided the evidence cited is strong enough and the recommendations fit with nursing principles and best practice. The Registered Nurses’ Association of Ontario’s guideline on End–of–life care during the last days and hours [18] has good research evidence for many of its recommendations with the remainder being supported by consensus from leading experts in palliative care nursing. This balance of evidence and consensus is required in many areas of nursing where there is little empirical research to guide recommendations. However, as can be seen in the ISO definition of a standard in the introduction to this chapter, consensus rather than evidence seems to be the basis for the development of HI standards.

Consensus building by experts, technical committees and national standards bodies is used by most international HI standards organizations to prepare new standards. However, the initial drafting process also includes consideration of evidence such as what standards already exist in the area under consideration and how effective these are. Many standards are developed using the experience and lessons from applications that are well advanced in some settings. For example, the ISO standard for patient health card medication data (ISO 21549–7) was agreed among a number of countries that had implemented and evaluated health cards. The standard is therefore based on consensus underpinned by experience of what works but not necessarily from formal evaluation studies or other empirical evidence. For other applications and supporting processes there is less experience and consensus is more difficult to obtain. Personal Health Records (PHRs), for example, are not yet widespread in most countries so ISO’s Health Informatics Technical Committee (TC215) published a Technical Report (TR) to summarise current knowledge on this topic and establish some definitions and principles (ISO/TR 14292). A standard may be developed for PHRs when more is known about any interoperability, safety or other requirements that would benefit from standardization.

If there is insufficient support for a full standard, ISO’s experts may agree to publish a Technical Specification (TS) – this can be used as a standard but only has consensus within the Technical Committee, not across all the national standards organizations. For example, ISO/TS 21547 specifies principles for security requirements for archiving electronic health records – these have been adopted by a number of countries and the TS will most likely be updated and promoted to a full standard based on their feedback.

After a published standard has been in use for several years it will be reviewed. Evidence is collated on how it is being used, whether it is achieving its objectives and whether it needs to be revised or withdrawn. Until recently, fitness for purpose and implementation evaluations have not been sufficiently accounted for in the consensus approach to development and review of HI standards. More attention is being paid now to questions such as costs and outcomes of standards implementation, implications for staff, patients, application providers and others.

A combination of consensus and evidence should be used for the development and review of HI standards but there is still a question about how they are approved and adopted i.e. who are the HI standards ‘authorities’ equivalent to AHRQ and NICE?

One of the greatest challenges in the standards world is that there are multiple sources for standards. Many different ‘recognized bodies’ and other organizations publish rules, guidelines and ‘agreed ways of doing things’, even in the specialised field of health informatics. Governments, Health Departments, Regulators and others adopt or develop their own HI standards for use in their countries and regions. Other organizations, such as the World Health Organization (WHO) and the International Council of Nurses (ICN), produce artefacts that are adopted as HI standards, for example, the WHO International Classification of Functioning Disability and Health (ICF) has been adopted in a number of countries as the standard to describe and measure health and disability [19].

A small but growing number of HI practice standards are developed by national and international professional bodies. Where no authoritative standard is available, the practice that is in common use may become known as the ‘default standard’ or ‘de facto’ i.e. it is widely accepted as best practice even though it has not been officially recognised or documented by a recognized body.

The most widely known HI SDOs are listed in Table 7.2 but perhaps more relevant to readers of this chapter are the national standards organizations in each country that contribute on their behalf to international developments and decide which standards should be adopted and promoted in their country. ANSI, the American National Standards Institute, is a good example of a national ‘recognized body’. Founded in 1918, ANSI is ‘the voice of the US standards and conformity assessment system’ [20]. Many national organizations of this kind will also develop standards for their own country, which they can then contribute to the international arena when other countries identify a similar need.

The standards produced by these organizations may be entirely consistent, differing only in presentation such as when different versions are published for technical experts and for clinicians. Unfortunately, consistency across SDOs is not always the case. A very basic example is the spelling of the word ‘organisation’. The European standards organisation (CEN) uses ‘s’ whereas ISO uses ‘z’. There are similar trivial examples specific to health informatics: the HI technical committee of ISO is called TC 215 – the equivalent committee in Europe is called TC 251.

At best, multiple HI standards lead to confusion; at worst they result in wasted resources and increase the risk of poor communication and unsafe practice and, concomitantly, risk to patient safety. To address existing inconsistencies and to prevent development of new competing standards, international HI standards organizations have established the Joint Initiative on SDO Global Health Informatics Standardization (see Table 7.2) [21]. Members of these SDOs consist mainly of HI experts and industry representatives. However, there is recognition that clinicians and health consumers should be part of standards development activity. In a presentation to the Joint Initiative Council meeting in October 2012, Professor Steven Kay emphasised the need for HI standards organizations to focus on ‘usability’ [22]. He cited the definition of usability from ISO 9241, a multi-part ISO standard covering ergonomics of human-computer interaction, i.e. usability is ‘the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use’. According to Kay, ‘users’ are presently seen as representatives and experts from organizations with a vested interest in the standard under development, not the clinicians and patients who are often the ultimate ‘consumer’ of the standard [23].

ISO has recognised the importance of consumer participation: ‘a “good” standard means one that creates a good product – a product that you will want to use because it is safe, fit for purpose, and easy to operate’ [24]. This sounds exactly what nurses, patients and public want from the systems and applications they use in health care. It is therefore essential that organizations representing, nurses, other clinicians and patients are an integral part of the ‘recognised bodies’ that develop, approve and adopt HI standards. Standards have a clear and defined development lifecycle or development process. In 2012, Canada Health Infoway [25] articulated a pan-Canadian Standards Product Life Cycle, which identified the four-stage development process for standards (Fig. 7.2). These include needs identification, options analysis, specification (standard) development, and maintenance [25; p.18].

This lifecycle is follows a traditional development process of identifying a health care challenge or ‘business need’ that requires a standards-based solution, exploring various options or potential standards solutions, proceeding to the adaptation of an existing standard or to developing a new standard, and finally reaching the stage of stability and on-going maintenance of that solution.

As standards progress through the development process, they may be awarded specific labels indicating their levels of maturity and readiness for use in health information applications [25]. These levels of maturity are intricately tied to the development process, as illustrated in Fig. 7.3. The Canadian Strategy Selection is the most introductory label of potential suitability for use as solution to a clinical challenge. The Canadian Draft for Use label is one that tells early adopters that this standard has undergone sufficient testing and validation to proceed with use but that future changes can still occur. The most important label is the Canadian Approved Standards, which designates the highest label of stability and that the standards is fully endorsed by the Infoway-sponsored inter-professional authorizing committees. When standards no longer meet business needs, they may become Canadian Deprecated or withdrawn from use.

Development, approval and adoption of standards follows a recognised standards lifecycle one example of which is given below with further detail in a later section.

From the preceding discussion, we can adapt the ISO definition of a standard and extend it with notes about purpose and functional usage to conclude that an HI standard is:

A document, established from evidence and by consensus and approved by a recognized body, that provides rules, guidelines or characteristics for activities or their results, in the field of information for health, and Health Information and Communications Technology (ICT).

The purpose of HI standards is to:

HI standards should meet the needs of users, be practical to implement and be sufficiently well specified to enable assessment of conformance. Clinicians and consumers of health care should be involved in the development, implementation and review of HI standards.

In this section, we consider the ‘rules, guidelines and characteristics of activities or their results’ that are needed to integrate information management and ICT into health care, particularly into nursing practice. For this purpose, the scope of health informatics can be considered as the scope of health care i.e. healthcare delivery; disease prevention and wellness promotion; public health and surveillance; clinical research [6].

HI also covers the use of information and ICT by patients, clinicians, managers, researchers and others. Many standards will be common to all, for example, anyone providing health care could be expected to have some level of competence in using technology, in accessing, understanding and using information to make decisions and in the secure management of information. Other chapters in this book go into more detail about specific topics such as education and competence, clinical and administrative applications, documentation systems, security, so the focus here will be on the standards that are available to support clinicians in their everyday practice including their support for healthcare consumers.

The term ‘eHealth’ is often used in place of ‘health informatics’ to convey a more general meaning i.e. ‘healthcare practice which is supported by electronic processes and communication’ [26; p42] – see also Chap.​ 2. This definition places ICT in perspective – it is a support for practice rather than a separate subject, at last for the non-specialist. This is why, as mentioned in the introduction, HI standards must be so closely related to practice standards. Take the example of record content standards, which specify what must or should be recorded about the care of a patient in a particular context. It is impossible to talk about standardizing the content of a document used for handing over care between shifts, for example, without first defining best practice for shift handover. In the same way it is impossible to have a standard for recording falls risk assessment without reference to the evidence based guideline for assessing a person’s risk for falls.

Examples of HI practice standards for all nurses and other clinical staff are given below, organised according to clinical eHealth themes identified by the NHS [26; p5]: