ISO TC 215 / Working Group 6

Scope TC215

Standardization in the field of health informatics to facilitate the creation, interchange and use of health-related data, information, and knowledge to support and enable all aspects of the health system

Scope WG6

Standardisation related to the application of information and communication technology in the domain of pharmacy and medication. This includes standardisation to improve patient safety and the efficiency and interoperability of information systems such as those used in researching, developing, regulating, supplying, prescribing, dispensing, administering and monitoring medicinal and pharmaceutical products, and documentation supporting implementation.

Mission WG

To help assure patient care through safe, effective and efficient use of medicines, which includes data exchanges with regulators, between supply chain partners, between solution providers for medication supporting softwares, databases and tools.

The WG6 Framework objectives are to

1. support the needs of stakeholders in developing and maintaining standards at WG6 to deserve their needs
2. coordinate WG6 efforts with the other WGs at ISO/TC215 and liaison organizations and
3. demonstrate value of the WG6 work in order to
4. attract new subject matter experts in WG6 sincenew standards are regularly in development
5. assess the adoption and use of the WG6 standards in health information and communication technology products.

Cooperation/engagement

• CEN (see about the “Vienna Agreement” : https://boss.cen.eu/ref/VA_FAQ.pdf)
• EMA, FDA, regulators, pharmaceutical industries
• ICH
• GS1
• HL7
• IHE
• SNOMED
• Specific projects such as EU “openMedicine” and “UNICOM“

Monday 23 October 2018

For the first time, TC 215 has proposed  ISO the nomination of experts who have provided an important contribution to standards development, and ultimately to patient safety.

This nomination took place during the opening ceremony for the fall 2018 meeting of TC 215, under the chairmanship of Mr Michael Glickman (USA).

7 from the 11 nominees participated to this ceremony.

The European Medicines Agency (EMA) published a press release about this recognition: https://www.ema.europa.eu/en/news/ema-experts-awarded-excellence-standards-development

Who we are – our programme

ISO TC 215/Working Group 6 supports the health enterprise through standardisation related to the application of information and communication technology in the domain of pharmacy and medication. This includes standardisation to improve patient safety and the efficiency and interoperability of information systems such as those used in researching, developing, regulating, supplying, prescribing, dispensing, administering and monitoring medicinal and pharmaceutical products, and documentation supporting implementation.

Working Group Mission

To help assure patient care through safe, effective and efficient use of medicines, which includes data exchanges with regulators, between supply chain partners, between solution providers for medication supporting software, databases and tools.

Cooperation/engagement

As part of Working Group 6 strategy, about once a year we meet representative of other standard development organisations.

The purpose is not to provide each other some frontal presentation or work-item list, but to engage a real discussion and see if one can receive useful advise and comments from one’s peer.

Our meetings

Working Group 6 meets usually twice a year face to face.

The second 2019 meeting took place in Daegu (South Korea). A successful meeting which was as well opportunity to meet a local hospital pharmacy (Daegu Catholic University Medical Center)

Our first 2019 meeting took place in Gothenburg, Sweden (13 – 17 April 2019) -picture above.

Our second 2018 meeting took place in Paestum (south of Napoli, Italy; see picture above) from 23 to 26 October 2018; there is a dedicated page to provide some highlight about our agenda and our decisions.

We met in Maringa, Brazil (30 April to 4 Mai, 2018) for the firsts 2018 f2f meeting. The team (picture above) was smaller than usual, but we had an outstanding week, dedicated to reviewing our work items.

As you can notice, WG 6 included many experts (picture above) in its fall 2017 meeting in Liverpool, UK (6 – 10 November 2017).