About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | EN ISO 17523:2016 |
|---|---|
| Title | Health informatics - Requirements for electronic prescriptions (ISO 17523:2016) |
| Work Item Number | 00251303 |
| Abstract/Scope | ISO 17523:2016 specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions. ISO 17523:2016 is constrained to the content of the electronic prescription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are out of scope of this International Standard, because they are more or less country or region specific, due to differences in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with these scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this International Standard. ISO 17523:2016 is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information object that authorizes a healthcare professional to legally dispense a medicinal product. ISO 17523:2016 specifies a list of data elements that can be considered as essential for electronic prescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). |
| Status |
Published
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| Reference Document |
ISO 17523:2016 (EQV)
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| date of Availability (DAV) | 2016-06-29 |
| ICS | 35.240.60 - IT applications in transport 35.240.80 - IT applications in health care technology |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
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| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2016-04-15 |
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| date of Availability (DAV) (2) | 2016-06-29 |
| date of Announcement (DOA) (3) | 2016-09-30 |
| date of Publication (DOP) (4) | 2016-12-31 |
| date of Withdrawal (DOW) (5) | 2016-12-31 |
Relations
| Supersedes | |
|---|---|
| Superseded by | prEN ISO 17523 rev |
| Normative reference (6) |
ISO 11238
ISO 11239 ISO 11240 ISO 11615 ISO 11616 ISO 17090-1 ISO 8601 ISO/TS 16791 ISO/TS 22220 ISO/TS 27527 |
| Sales Points |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.