[App collects personal health information] allow data to be imported or 5 SHOULD[IF] exported from the app. Related Regulations and Standards Direct Project Applicability Statement for Secure Health Transport HL7 Consolidated CDA HL7 FHIR STU. SMART ON FHIR. IEEE 10073 Personal Health Data Standards information Exchange standards for Personal Health Environment (Netherlands) “MedMij” Includes HL7 Detailed Clinical Models (DCM), which provide context for discrete clinical data (e.g., systolic blood pressure); the standard is being used in the Netherlands. Implementation Guidance None: recommendations are solicited. 3.4.8 Notifications and Alerts This category is about notifications and alerts, which may be used to inform consumers of important situations that they should know about. This includes, but is not limited to, information about the app itself (e.g., important updates) or about the health information that the app handles (e.g., the specific consumer’s personal health data warrants special attention). Conformance No. Strength Requirement Opt-in consent is required by the account holder before receiving notifications 1 SHALL and alerts from an app. To consent to receiving a notification or alert from an app, the account holder is 2 SHALL informed of both the content and channel (SMS, push notification, email, etc.) of the notification or alert. An account holder can change consent decisions about notifications and alerts 3 SHALL through settings available on the device on which the app was downloaded. Notifications and alerts contain the least amount of information necessary for 4 SHALL the recipient of the alert to take a focused action. [app alerts notify user of conditions such as or or “abnormal” “exceptional” 5 SHALL [IF] of range”] Document or reference the sources (evidence base) of the “out formulas/algorithms upon which such alerts and notifications are based. As permitted by the account holder and agreed to by recipients, notifications 6 SHOULD and alerts may be sent to the account holder and/or to another person or entity. Provide alerts to notify the user of potential faults that cause 7 SHOULD inconvenience or harm to the user, e.g., low battery alerts. Notify the user in case of external interruptions or delays (e.g., loss of network 8 SHOULD connection, database problem, lengthy operation)
5 SHOULD[IF] [App collects personal health information] allow data to be imported or exported from the app. Related Regulations and Standards Direct Project Applicability Statement for Secure Health Transport HL7 Consolidated CDA HL7 FHIR STU. SMART ON FHIR. IEEE 10073 Personal Health Data Standards “MedMij” information Exchange standards for Personal Health Environment (Netherlands) Includes HL7 Detailed Clinical Models (DCM), which provide context for discrete clinical data (e.g., systolic blood pressure); the standard is being used in the Netherlands. Implementation Guidance None: recommendations are solicited. 3.4.8 Notifications and Alerts This category is about notifications and alerts, which may be used to inform consumers of important situations that they should know about. This includes, but is not limited to, information about the app itself (e.g., important updates) or about the health information that the app handles (e.g., the specific consumer’s personal health data warrants special attention). Conformance No. Strength Requirement 1 SHALL Opt-in consent is required by the account holder before receiving notifications and alerts from an app. 2 SHALL To consent to receiving a notification or alert from an app, the account holder is informed of both the content and channel (SMS, push notification, email, etc.) of the notification or alert. 3 SHALL An account holder can change consent decisions about notifications and alerts through settings available on the device on which the app was downloaded. 4 SHALL Notifications and alerts contain the least amount of information necessary for the recipient of the alert to take a focused action. 5 SHALL [IF] [app alerts notify user of conditions such as “abnormal” or “exceptional” or “out of range”] Document or reference the sources (evidence base) of the formulas/algorithms upon which such alerts and notifications are based. 6 SHOULD As permitted by the account holder and agreed to by recipients, notifications and alerts may be sent to the account holder and/or to another person or entity. 7 SHOULD Provide alerts to notify the user of potential faults that cause inconvenience or harm to the user, e.g., low battery alerts. 8 SHOULD Notify the user in case of external interruptions or delays (e.g., loss of network connection, database problem, lengthy operation)
CMHAFF_STU_Ballot_Draft.docx