Information Standards Board

Health and Social Care Information Centre. ISB0160. Clinical risk management its application in the deployment and use of health IT. UK Information Standard Board for Health and... 

By 2009 the UK National Programme for IT was being overseen by a body called Connecting for Health (CfH) and, working with the UK Information Standards Board, two new standards were drafted and approved ... 

ISB (2009a) DSCN 14/2009 Application of patient safety risk management to the manufacture of health software. Information Standards Board for Health and Social Care ISB (2009b) DSCN 18/2009 Application of patient safety risk management to the deployment and use of health software. Information Standards Board for Health and Social Care MoD (1986) Def Stan 00-58 HAZOP studies on systems containing programmable electronics (withdrawn). Ministry of Defence... 

We then look at the specific pressures faced by health organisations in complying with 1EC80001 and consider how the new National Health Service (NHS) Information Standards Board (ISB) chnical safety management system standard can be used as a framework to demonstrate comphance with these emerging requirements. 

CfH were supported by the NHS Information Standards Board in viewing the risks associated with unclassified domains (such as maternity, prescribing/dis-pensing and A E triage) as being too important to remain unregulated. 

Great Britain s Safety Management Information System (GB SMIS) administered by the Rail Safety and Standards Board (RSSB) ... 

The key piece of information held on a tag is the electronic product code (EPC, standards for which were developed by the Auto-ID Center). This number plate is unique to each tag. The unique number can then be linked to information about the product to which it is attached, for example about when and where the product was made, where its components came from and shelf life details. Some tags may hold this additional information on board however the intention is that most tags will only hold the EPC and additional information will be stored remotely, on a database linked to the management system. 

Raw data must be analyzed and transformed into a format useful for specific purposes. Summary tables, graphs, and geographic distributions are some of the formats used for data display. Air quality information often consists of a large body of data collected at a variety of locations and over different seasons. Table 15-3 shows the tabular format used by the California Air Resources Board to reduce ozone hourly measurements to a format which shows information about compliance with air quality standards (6). The format has location, maximum values, annual means, and number of occurrences of hourly values above a given concentration as a function of the month of the year. One can quickly determine which areas are violating a standard, at what time of the year elevated concentrations are occurring, and the number of good data points collected. 

Seeing the success of the UNAMAP BBS, EPA s Office of Air Quality Planning and Standards started a BBS for information on regulatory models in June 1989. This has expanded to a BBS called TTN, Technology Transfer Network. This BBS, in Durham, NC, is reached on (919) 541-5742 and the system operator on (919) 541-5384. A part of this BBS called SCRAM, Support Center for Regulatory Air Models, contains model FORTRAN codes, model executable codes for use on personal computers, meteorological data, and in some cases model user s guides. Much of the information is downloaded in "packed" form, and software to unpack the files must also be downloaded from the bulletin board. 

The mean time to failure of various instrumentation and equipment parts would be known from the manufacturer s data or the employer s experience with the parts, which then influence inspection and testing frequency and associated procedures. Also, applicable codes and standards—such as the National Board Inspection Code, or those from the American Society for Testing and Materials, American Petroleum Institute, National Fire Protection Association, American National Standards Institute, American Society of Mechanical Engineers, and other groups—provide information to help establish an effective testing and inspection frequency, as well as appropriate methodologies. 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

Most circuit boards are FR-4 boards that meet standards for fire safety by the use of brominated epoxy resins in which the reactive flame-retardant tetrabromobisphenol A (TBBPA) forms part of the polymeric backbone of the resin. Alternative flame-retardant materials are used in only 3-5 per cent of the FR-4 boards, but additional alternative flame-retardant materials are also imder development. Little information exists concerning the potential environmental and human health impacts of the materials which are being developed as alternatives to those used today that are based on brominated epoxy resins. 

Certificates issued by the British Board of Agrement (BBA) cover new or innovative construction products not covered by existing British Standards and Codes of Practice. These certificates, which are the result of assessment by BBA based on manufacturers information and on independent testing, also provide information on projected lifetimes. In future, under the European Construction Products Directive, product performance details including durability will be given on the label of each CE marked product. An example of how this is applied will be described in the next section. 

In addition to the required elements of an informed consent form, an IRB can and may require other standard information or signatures be added to all informed consenf forms being reviewed by the board. 

JFSSG (1999a) Survey of retail paper and board food packaging materials for polychlorinated biphenyls (PCBs), Food Surveillance Information Sheet 174, available from the Food Standards Agency, Room 303b, P.O. Box 31037, London SW1P 3WG, Tel. No. +44 (0)20 7238 6245/6150, fax +44 (0)20 7238 6330 or email informationcentre foodstandards.gsi.gov.uk. 

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