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1a. Project Name

Unique Mobile Health Application Identifier (UMHAI)

1b. Project ID

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

Apr 12, 2021

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Mobile Health

2b. Co-Sponsor WG

Health Care Devices

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2d. Project Facilitator

Gora Datta, Matthew Graham

2e. Other Interested Parties (and roles)

IEEE-SA
ISO/TC215
FDA Center for Digital Health

2f. Modeling Facilitator

Paul Petronelli

2g. Publishing Facilitator

Matthew Graham

2h. Vocabulary Facilitator

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

3a. Project Scope

Attachments

3b. Project Need

The proliferation of Digital Health tools, including mobile health apps and wearable sensors, holds great promise for improving human health[1]. The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors. As per US-FDA: “The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.”
As of 2019, there are between 400,000 to 500,000[2] health, wellness and fitness apps that run on smartphones, watches, tablets, and other mobile devices, available for download from platform-specific application stores such as the Apple App Store (iOS) and Google Play (Android). This number has rapidly grown from 325,000[3] apps in 2017.
Soon we will have clinicians globally prescribing mobile health apps to patients, similar prescribing medicines or medical devices[4]. In fact,German federal government passed the Digital Healthcare Act (DVG) in Nov 2019[5] and two health apps are already officially available, as of Oct 2020, for prescription[6]. Other countries are also marching down this path.
However, before this becomes as common as prescribing a medicine or a medical device by a provider, the mobile health app needs to be safe/secure/accurate not only for the individual user/patient/family member but also for the clinician/payer/provider/regulatory community. Given the era of cybersecurity and its impact on healthcare[7], it is critical that the healthcare informatics standards community looks into this matter now.
Mobile health apps have access to highly detailed, personally identifiable and clinical information about end-users. Security and privacy are big issues, raising questions about permission control and confidentiality, as well as the integrity of the infrastructure and the individual. There is also a need to clarify how to ensure practicalities of data storage and management, availability and maintenance of the network, as well as compatibility and interoperability. [8]
However, there is no established mobile health app certification process. It is a possibility that we will see a proliferation of non-standardized, country-specific, siloed certification processes being established over the next few years. We are already seeing efforts[9] in this area.
Besides establishing a certification and associated conformity assessment process for mobile health apps, a need is also envisaged for establishing a global Mobile Health App Registry.

3c. Security Risk

Unknown

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

3m. External Vocabularies

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Resources, New Product Definition

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new standard

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

6f. Other Stakeholders

6g. Vendors

6g. Other Vendors

6h. Providers

6h. Other Providers

6i. Realm

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



Version

4

Modifier

Matthew Graham

Modify Date

Apr 16, 2021 13:43

1a. Project Name

Unique Mobile Health Application Identifier (UMHAI)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1e. Today's Date

Apr 12, 2021

2a. Primary/Sponsor WG

Mobile Health

2b. Co-Sponsor WG

Health Care Devices

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2d. Project Facilitator

Gora Datta, Matthew Graham

2e. Other Interested Parties (and roles)

IEEE-SA
ISO/TC215
FDA Center for Digital Health

2f. Modeling Facilitator

Paul Petronelli

2g. Publishing Facilitator

Matthew Graham

3b. Project Need

The proliferation of Digital Health tools, including mobile health apps and wearable sensors, holds great promise for improving human health[1]. The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors. As per US-FDA: “The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.”
As of 2019, there are between 400,000 to 500,000[2] health, wellness and fitness apps that run on smartphones, watches, tablets, and other mobile devices, available for download from platform-specific application stores such as the Apple App Store (iOS) and Google Play (Android). This number has rapidly grown from 325,000[3] apps in 2017.
Soon we will have clinicians globally prescribing mobile health apps to patients, similar prescribing medicines or medical devices[4]. In fact,German federal government passed the Digital Healthcare Act (DVG) in Nov 2019[5] and two health apps are already officially available, as of Oct 2020, for prescription[6]. Other countries are also marching down this path.
However, before this becomes as common as prescribing a medicine or a medical device by a provider, the mobile health app needs to be safe/secure/accurate not only for the individual user/patient/family member but also for the clinician/payer/provider/regulatory community. Given the era of cybersecurity and its impact on healthcare[7], it is critical that the healthcare informatics standards community looks into this matter now.
Mobile health apps have access to highly detailed, personally identifiable and clinical information about end-users. Security and privacy are big issues, raising questions about permission control and confidentiality, as well as the integrity of the infrastructure and the individual. There is also a need to clarify how to ensure practicalities of data storage and management, availability and maintenance of the network, as well as compatibility and interoperability. [8]
However, there is no established mobile health app certification process. It is a possibility that we will see a proliferation of non-standardized, country-specific, siloed certification processes being established over the next few years. We are already seeing efforts[9] in this area.
Besides establishing a certification and associated conformity assessment process for mobile health apps, a need is also envisaged for establishing a global Mobile Health App Registry.

3c. Security Risk

Unknown

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

4a. Products

FHIR Resources, New Product Definition

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

Version

3

Modifier

Matthew Graham

Modify Date

Jan 20, 2021 19:55

1a. Project Name

Unique Mobile Health Application Identifier (UMHAI)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Mobile Health

2b. Co-Sponsor WG

Health Care Devices

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2d. Project Facilitator

Gora Datta, Matthew Graham

2e. Other Interested Parties (and roles)

IEEE-SA
ISO/TC215
FDA Center for Digital Health

2f. Modeling Facilitator

Paul Petronelli

2g. Publishing Facilitator

Matthew Graham

3b. Project Need

The proliferation of Digital Health tools, including mobile health apps and wearable sensors, holds great promise for improving human health[1]. The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors. As per US-FDA: “The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.”
As of 2019, there are between 400,000 to 500,000[2] health, wellness and fitness apps that run on smartphones, watches, tablets, and other mobile devices, available for download from platform-specific application stores such as the Apple App Store (iOS) and Google Play (Android). This number has rapidly grown from 325,000[3] apps in 2017.
Soon we will have clinicians globally prescribing mobile health apps to patients, similar prescribing medicines or medical devices[4]. In fact,German federal government passed the Digital Healthcare Act (DVG) in Nov 2019[5] and two health apps are already officially available, as of Oct 2020, for prescription[6]. Other countries are also marching down this path.
However, before this becomes as common as prescribing a medicine or a medical device by a provider, the mobile health app needs to be safe/secure/accurate not only for the individual user/patient/family member but also for the clinician/payer/provider/regulatory community. Given the era of cybersecurity and its impact on healthcare[7], it is critical that the healthcare informatics standards community looks into this matter now.
Mobile health apps have access to highly detailed, personally identifiable and clinical information about end-users. Security and privacy are big issues, raising questions about permission control and confidentiality, as well as the integrity of the infrastructure and the individual. There is also a need to clarify how to ensure practicalities of data storage and management, availability and maintenance of the network, as well as compatibility and interoperability. [8]
However, there is no established mobile health app certification process. It is a possibility that we will see a proliferation of non-standardized, country-specific, siloed certification processes being established over the next few years. We are already seeing efforts[9] in this area.
Besides establishing a certification and associated conformity assessment process for mobile health apps, a need is also envisaged for establishing a global Mobile Health App Registry.

3c. Security Risk

Unknown

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

4a. Products

FHIR Resources, New Product Definition

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

Version

2

Modifier

Matthew Graham

Modify Date

Jan 20, 2021 19:53

1a. Project Name

Unique Mobile Health Application Identifier (UMHAI)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Mobile Health

2b. Co-Sponsor WG

Health Care Devices

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2d. Project Facilitator

Gora Datta, Matthew Graham

2e. Other Interested Parties (and roles)

IEEE-SA
ISO/TC215
FDA Center for Digital Health

2f. Modeling Facilitator

Paul Petronelli

2g. Publishing Facilitator

Matthew Graham

3c. Security Risk

Unknown

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

4a. Products

FHIR Resources, New Product Definition

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

Version

1

Modifier

Matthew Graham

Modify Date

Oct 23, 2020 22:26

1a. Project Name

Unique Mobile Health Application Identifier (UMHAI)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Mobile Health

2d. Project Facilitator

Matthew Graham

3j. Backwards Compatibility

No