Standards for Medical Informatics and Health Information Systems

Standards for Medical Informatics

Patient Data Standards

Standards for Medical Informatics 1III. Patient data Standards for Medical Informatics Standards A set of standards established to achieve the unification of the characteristics of a given performance or technological process, by anyone or in any case produced; Ensures interoperability between different computer systems and preserves data stored with one system when a new system is acquired.

At the international level, a lot of resources are spent on standardisation activities specific to medical informatics, involving both authorities and large public and private organisations, as well as manufacturing industries and end- users.

2III. Patient data Standards for Medical Informatics Standards . In addition, on the more technological side, sophisticated equipment (especially for patient monitoring and for the generation of images to support diagnostic activities) is frequent in the healthcare sector, with pressing rates of innovation and updating.

. Uniform, standards-based interfaces will make it possible to keep pace with technological advances, in a gradual and non- traumatic way for the information system as a whole.

3III. Patient data Standards for Medical Informatics Standards In other words, advances in information technology and communication networks now make it possible for computers to communicate with each other for two types of cooperation:

1. management: make two different applications interact for the exchange of requests and results (prescriptions for drugs and analysis, discharge letter, booking of services through unified booking centers);
2. clinic: Timely access at the time of need to clinical information stored in applications, including remote ones, managed by other healthcare professionals or sophisticated equipment.

Standards Issuing Channels

4III. Patient data Standards for Medical Informatics Standards Issuing Channels The English word "standard" is commonly used with different meanings. In fact, it is usually used for three types of documents produced according to completely different rules:

1. Voluntary standards. These are documents approved by consensus according to a precise process within one of the official standards bodies (e.g. ISO, CEN, UNI). Under the European Union's (EU), national governments and the EU are required to pass generic laws and directives, leaving it to regulatory bodies to produce, approve, adopt, maintain and distribute detailed enforcement rules. Representatives of industries interested in a given sector, users, academia, research and authorities meet within the framework of a voluntary Technical Commission, and produce standards according to a pre-established process.

5III. Patient data Standards for Medical Informatics Standards Issuing Channels 2. De facto standard. These are rules or products that impose themselves on the market and therefore represent a precise reference that must be taken into account. In the IT industry, the most obvious example is the Windows operating system for personal computers. The use of de facto standards in a particular software application is based on considerations of convenience. Alongside these a posteriori standards, standards produced by consortia of industries outside the sector of official Standards Bodies are spreading. The best-known example is the W3C, the consortium that produces rules for XML and a number of standards for the use of the Web.

6III. Patient data Standards for Medical Informatics Standards Issuing Channels 3. Rules imposed by the authorities. These are laws, regulations and circulars that impose certain behaviors and/or standard messages and/or definitions of data elements (for example, paper or electronic forms for the notification of events of health interest, certificates, reimbursement requests, prescriptions). In our case, they can be at national, regional, local level (municipality or health authority).

Scope of Medical Informatics Standards

7III. Patient data Standards for Medical Informatics Scope of the standards 1. Information technology and telematics in general This sector includes all operating systems, programming languages, generic communication standards (for example those on Open Systems described by the ISO-OSI levels), query languages (e.g. . SQL). The healthcare industry can only marginally influence the production of these standards, but must instead be able to select the appropriate ones for the applications to be developed.

8III. Patient data Standards for Medical Informatics Scope of the standards 2. Health Informatics These are all the standards that have as their object information technology (and telematics) in the health sector. Alongside the rules issued by the National Health System (e.g. on the government information system, or on the record tracks for regional reimbursements), there are the voluntary European standards of CEN (relating above all to the definition of messages) and some UNI standards. The "Standard Developing Organizations" (SDOs) in the USA are very active, recognized by ANSI (the North American standards body) as they adopt a ballot and approval process according to the directives of the ANSI itself. These include IEEE (especially with regard to equipment), ASTM and HL7 (messages especially in the hospital environment). In addition, there are organizations outside the official regulatory circuit, such as DICOM (images).

9III. Patient data Standards for Medical Informatics Scope of the standards 3. Clinical Data Specific Standards These are the specific standards - within health informatics - to facilitate the dissemination and to increase the effectiveness of applications that manage clinical data, in particular for the management of an electronic health record by different healthcare professionals. The field is particularly complex, but it is also the topic of greatest interest to end-users (doctors) due to its potential impact on daily clinical practice.

DICOM Standard

10III. Patient data Standards for Medical Informatics DICOM · Digital medical images were initially stored in different formats by the hardware companies. This created big problems in departments with different apparatuses.

. With the introduction of computed tomography (CT) followed by other digital diagnostic modalities in the 1970s, and the increasing use of computers in clinical applications, the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) recognized the emerging need for a standard method for transferring images and associated information between instruments made by different manufacturers. These tools produce a variety of digital image formats.

11III. Patient data Standards for Medical Informatics DICOM American College of Radiology (ACR), Founded in 1923, it is a non-profit organization of the medical professions made up of radiologists, oncologists, radiation therapists, nuclear physicians, and medical physicists. The journal is the Journal of the American College of Radiology (JACR). NEMA, Created in 1926 by the merger of the Electric Power Club and the Associated Manufacturers of Electrical Supplies, it provides a forum for the standardization of electrical equipment, encouraging consumers to choose from a range of safe, functional and compatible products. DICOM = Digital Imaging and Communication in Medicine

12III. Patient data Standards for Medical Informatics DICOM The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) formed a joint commission in 1983 to develop a standard with the aim of: Promote the communication of digital image information, regardless of the device manufacturer; Facilitate the development and expansion of picture archiving and communication systems (PACS) that could also interface with other hospital information systems; Enable the creation of databases of diagnostic information that could be queried by a wide variety of geographically distributed instrumentation.

13III. Patient data Standards for Medical Informatics DICOM · ACR-NEMA Standards Publication No. 300-1985, was published in 1985 and was referred to as version 1.0.

. This was followed by two more revisions: No. 1, dated October 1986 and No. 2, dated January 1988.

· ACR-NEMA Standards Publication No. 300-1988, published in 1988 was referred to as version 2.0. Includes version 1.0 and subsequent revisions. In addition, it provides for the management of display devices, introduces a new scheme to identify an image, and adds data elements to increase specificity in the image description. DICOM Digital Imaging and Communications in Medicine NEMA, Suite 900 1300 North 17" Street Rosslyn, VA 22209 Ph: (703) 475-9217 http://dicom.nema.org dicom@medicalimaging.org

14III. Patient data Standards for Medical Informatics DICOM . In 1993, the ACR and NEMA published another revision, called DICOM 3.0, that could be used in a network-based environment.

. The DICOM 3.0 standard, which encompasses both communication protocols and file format, provides the foundation for the transfer of digital medical images between systems. DICOM Digital Imaging and Communications in Medicine NEMA, Suite 900 1300 North 17" Street Rosslyn, VA 22209 Ph: (703) 475-9217 http://dicom.nema.org dicom@medicalimaging.org

15III. Patient data Standards for Medical Informatics DICOM . DICOM is a constantly evolving standard, updates are the responsibility of the DICOM Committee; Proposals for change come from users who are members of the Committee, are evaluated by the Committee and eventually the standard is updated. Of course, care must be taken to maintain compatibility between the various versions. http://dicom.nema.org/ DICOM Digital Imaging and Communications in Medicine NEMA, Suite 900 1300 North 17" Street Rosslyn, VA 22209 Ph: (703) 475-9217 http://dicom.nema.org dicom@medicalimaging.org

DICOM 3.0 Standard

16III. Patient data Standards for Medical Informatics DICOM 3.0 The DICOM 3.0 standard differs from previous versions in a few but fundamental points:

• Overcome network connection issues, since previous versions were designed only for point-to-point connections; this aspect had a particular weight in decreeing the success of the standard, thanks to the adoption of the ISO-OSI reference model and the TCP/IP protocol.
• Defines specific standards of compliance with DICOM 3.0 to which manufacturers must adhere, whereas previous versions only described the minimum levels of compliance.
• It is structured as a multi-part document and it's therefore easy to both upgrade and integrate.
• Specify syntax and semantics both of the commands and of the associated data.
• Service classes define specific operations (Send, Query, etc.) in client- server mode.

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