“Formal” standardization documents are those published by Bodies who are signatories of the World Trade Organization Technical Barriers to Trade Agreement (WTO-TBT Agreement), containing the Code of Good Practices for the Preparation, Adoption and Application of Standards. Examples of such Bodies, with different geographic scopes (national, regional and international) are the British Standard Institute (BSI); the European Standardization Committee (CEN); and the International Organizational for Standardization (ISO).

The WTO-TBT Code of Good Practices is reflected at these bodies’ internal operational procedures (BSI Procedures, CEN Internal Regulations; ISO Directives). In practice this means documents published by them are developed in strict respect of principles such as

• Openness and Transparency;
• Effectiveness and Relevance;
• Coherence;
• Impartiality and Consensus;
• Sustainable Development.

which increase its credibility in the market. Documents published by other entities are considered “proprietary” standardization documents and do not have a way to assure users of their method of development. This can negatively affect its exploitation.

In this framework, the HEALINT Protocol is considered a proprietary standardization document and, in order to increase its dissemination, expand its exploitation potential and assure its sustainability after the project lifetime, the HEALINT Consortium, taking advantage of one of its partners’ (KIC) experience in the formal standardization world, presented the HEALINT Protocol to BSI and proposed it as a new work item to be submitted to ISO for publication as an International Workshop Agreement.

The proposal was approved and included in BSI’s and ISO’s Work Plans for 2020. The HEALINT Protocol was distributed by ISO to their 160+ members which were invited to participate in the development of the document and an international work group was constituted for that purpose. The group hold five Workshops during spring and summer of 2020, where 88 Experts, representing 63 organizations from 23 countries, actively participated to discuss, line by line, the contents of the HEALINT Protocol, reaching international consensus on the contents of IWA 35:2020 Quality of learning environments for students in healthcare professions – Requirements for healthcare education providers in care settings, which was published by ISO on November 17, 2020.