GIO Digital Health Workshop / 9th GIO roundtable

Honored to have been the rapporteur of the GIO Digital Health Workshop (#digitalhealth) at the 9th GIO roundtable ?(#MWC 2022 Barcelona).

Chinese and European experts from industry, regulators and academy (BSI, COCIR, GIO, DIGITALEUROPE, HL7 Europe, CADMI, 6GHI, NIFDC, ZVEI, TM Forum, ETSI, University of Surrey, 5GSA)

met and discussed about:

1. Industrial environment shaping and experience sharing in innovative digital health area industry demand, development, status, challenges, goals, problems, etc.)
2. Standardization practices of consumer products in the healthcare area?(e.g. policies, regulations, standards, etc.)
3. Advances in data sharing for consumer products

Several interesting topics highlighted, among them:?

• the regulations for #ai in healthcare and the qualification of smart hardware;?
• the gap between investors attention and actual progresses, slower than in other industries;?
• the need of shaping "trust" in digital health
• the role of #hl7 #fhir in nowadays digital health ecosystems, as part of a coherent supporting set of standards. Digital health ecosystems are more and more characterized as system of ecosystems in which medical and consumer devices coexist.

Trust; Transparency; Collaboration of ecosystems; Interoperability; Agility and flexibility; Consumer/stakeholders needs ; SMART objectives and Global Cooperation the identified keywords.?

It has been proposed to establish a multi-stakeholder (regulator, industry, health providers, academy,..) working group to follow up with the topics identified during the workshop.

AI and Medical Device Regulations, Research and Standards the three main subjects, including:

• AI in healthcare;
• smart hardware/consumer devices;
• quality labeling standards for consumer devices, as done for Health and wellness apps (CEN ISO/TS 82304-2:2021);
• best practice sharing;
• support the development of coherent standards' set, including HL7 FHIR artefacts for consumer devices.??

A pragmatic incremental approach based on concrete, specific and achievable objectives has been suggested.