Data Platform: Data acquisition from medical devices, PREMs and PROMs – (i) Mobile Devices, (ii) Wearable Devices – (ii-a)Sensors

Role this area should play in the mHealth space

The proliferation of Digital Health tools, including mobile health apps and wearable sensors, holds great promise for improving human health1. 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.”

Numerous IoT based systems are in deployment in the healthcare industry in order to monitor and diagnose the current state and to facilitate the wellbeing of a patient in an autonomous way2.

In healthcare, increasing data from a mobile devices/apps are being acquired using two methods: PRO (patient reported outcomes) & PRE (patient reported experiences). PROMs are tools used to measure patient-reported outcomes (PROMs). PROMs are standardized, validated questionnaires that are completed by patients. Whereas, PREMs gather information on patients’ views of their experience. PREMs do not look at the outcomes of care but the impact of the process of the care on the patient’s experience3.

Current challenges and limitations
  • Evolving area
  • Nascent technologies
  • Standards are emerging

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 healthcare4, 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 interoperability5. 

 

What benefit could this bring to adopters of this innovation?
Safe, secure and quality data.
How does it contribute to major EU policy priorities? (e.g. EHDS, COVID-19, DTHC etc.)
Data acquisition is a key contributor to satisfying EU policy priorities:

  • EHDS – data acquisition mobile platform (devices, IoT, sensors) 
  • Combatting COVID-19 – for example: contact tracing using mobile devices
  • DTHC
    • Citizens’ secure access to their health data, also across borders – enabling citizens to access their health data across the EU;
    • Personalised medicine through shared European data infrastructure – allowing researchers and other professionals to pool resources (data, expertise, computing processing and storage capacities) across the EU;
    • Citizen empowerment with digital tools for user feedback and person-centred care – using digital tools to empower people to look after their health, stimulate prevention and enable feedback and interaction between users and healthcare providers.

Examples

SMART on FHIR API

SMART on FHIR API

Approach or solution SMART Health IT was launched with a New England Journal of Medicine article6 proposing a universal API (application programming interface) to transform EHRs into platforms for substitutable iPhone-like apps   Organisation or initiative SMART Health IT   URL or reference https://smarthealthit.org/  ... ...

Data Acquisition Standard: HL7 FHIR SDC

Data Acquisition Standard: HL7 FHIR SDC

Approach or solution Structured Data Capture (SDC) published by HL7 International – FHIR Infrastructure Work Group is a standard that facilitates data acquisition.   Organisation or initiative HL7 International   URL or reference http://build.fhir.org/ig/HL7/sdc/   Summary of the innovation In FHIR SDC, forms are represented... ...

What is on the horizon?
  • Wearable technology in healthcare includes electronic devices that consumers can wear, like Fitbits and smartwatches, and are designed to collect the data of users’ personal health and exercise9.
  • Non-standard form factors such as wearables – like smart clothing: clothing items that have been enhanced with technology to add functionality beyond that of the traditional use.”10.
  • Connected Vehicles and healthcare11