HL7 Unique Mobile Health App Identifier (UMHAI) (Jira PSS-1867)

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 needs to be a means to identify the application-patient instance. This project will define a Unique Mobile Health App Identifier (UMHAI). With UMHAI identifying a specific application/device/person, UMHAI can facilitate the development implementation of registries related to application management (updates, recalls), clinical practice (getting patient data to clinician), and research.

While not in the scope of this project, it should be noted that 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.

In addition, 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.