Responsible organization

Responsibilities are split: the manufacturer supplies the software and the information to run it safely, and the responsible organization installs, configures and operates it. For consumer apps, the user and the responsible organization are often the same person.

entity accountable for the use and proper operation of a HEALTH SOFTWARE PRODUCT Note 1 to entry: An accountable entity is, for example, a hospital, a healthcare provider, or a telehealth organization. [SOURCE: IEC 60601-1:2005, 3.101, modified – Replaced " maintenance of an ME EQUIPMENT or an ME SYSTEM" by " proper operation of a HEALTH SOFTWARE PRODUCT".]

IEC 82304-1:2016, clause 3.12

entity accountable for the use and maintenance of a MEDICAL DEVICE or combination of MEDICAL DEVICES Note 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a lay person. In home use applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person. Note 2 to entry: Education and training are included in "use." [SOURCE: IEC 60601-1:2005, 3.101, modified – The reference in the definition to ‘an ME EQUIPMENT or ME SYSTEM’ has been replaced with ‘a MEDICAL DEVICE OR COMBINATION OF MEDICAL DEVICES’ and 'operator' has been replaced by 'USER' in the note to entry.]

IEC 62366-1:2015+AMD1:2020, clause 3.12