BS IEC 82304-1:2016 pdf free download – Health software
4.2 H EALTH SOFTWARE PRODUCT use requirements
The MANUFACTURER shall determine and document:
a) requirements that address the INTENDED USE ;
b) interface requirements, including USER interface requirements where applicable;
NOTE 1 In contrast to the USER interface specification as part of the HEALTH SOFTWARE PRODUCT system requirements, USER interface requirements do not describe technical (realization) requirements. They describe the purpose of the technical requirements.
EXAMPLE “The displayed information shall be readable from a distance of 3 m in an emergency unit.”
NOTE 2 IEC 62366-1 :201 5 provides a process to establish USER interface requirements.
c) requirements for immunity from or susceptibility to unintended influence by other software using the same hardware resources;
d) privacy and SECURITY requirements addressing areas such as authorised use, person authentication, health data integrity and authenticity, and protection against malicious intent;
NOTE 3 See 7.2.3.1 and IEC TR 80001 -2-2 (list of SECURITY capabilities) for further information on SECURITY aspects.
e) requirements for ACCOMPANYING DOCUMENTS such as instructions for use (see 7.2.2);
f) requirements to support:
1 ) upgrades from previous versions, including maintaining data integrity, and compatibility with prior versions,
2) rollback to the previous version after upgrade,
3) timely SECURITY patches and updates,
4) software distribution mechanism that ensures integrity of installation,
5) decommissioning, irreversible deletion, transfer and/or retention of data;
g) requirements derived from applicable regulation, including rules for protected information.
NOTE 4 In some jurisdictions, data protection regulations (e.g. European data protection directive 95/46/EC,revised in 201 6) mandate citizens to maintain control over their personal data such as to delete or export data.European directive 95/46/EC will be replaced by the European General Data Protection Regulation (201 6/679) on 25 May 201 8.
4.5 System requirements
The MANUFACTURER shall specify and document the system requirements for the HEALTH
SOFTWARE PRODUCT . These requirements shall include the functionality for INTENDED USE and,as applicable:
a) inter-operability;
b) localization and language support;
c) RISK CONTROL measures that have to be implemented in the HEALTH SOFTWARE PRODUCT at system level, based on the initial RISK ASSESSMENT of 4.1 ;
d) USER interface specification;
e) requirements on the software and hardware platforms for the HEALTH SOFTWARE PRODUCT
to function as expected under expected load, and with required performance levels;
f) features that allow for SECURITY compromises to be detected, recognized, logged, timed,and acted upon during normal use;
g) features that protect essential functions, even when the software SECURITY has been compromised;
h) methods for retention and recovery of product configuration by an authenticated privileged USER .
The HEALTH SOFTWARE PRODUCT system requirements shall meet the HEALTH SOFTWARE PRODUCT use requirements (see 4.2).
NOTE 1 The website http://www.himss.org/library/interoperability-standards/what-is-interoperability provides one source of information on inter-operability.
NOTE 2 Technical requirements for the USER interface can include display colour, character size, or placement of the controls.
NOTE 3 The typical software platform includes, but is not limited to: operating system, device drivers, software libraries, and other USER application(s).
NOTE 4 There is not necessarily a difference between SOFTWARE SYSTEM requirements of IEC 62304:2006, 5.2.1 and and HEALTH SOFTWARE PRODUCT system requirements.