Telemedicine and healthcare data: protocols, standards and pandemic acceleration

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The pre-pandemic frame

Before the pandemic, telemedicine in Italy had a frame of principles but very partial adoption. The national reference was Telemedicina — Linee di indirizzo nazionali (National Telemedicine Guidelines), approved by the Ministry of Health Technical Board and endorsed by the State-Regions Conference on 20 February 2014. The AGENAS guidelines defined terminology, types of service and clinical scope and had been adopted in differentiated forms by the Regions.

The types of service identified in the 2014 document have become the shared vocabulary of the field:

• Televisit — medical act in which the professional interacts remotely with the patient; produces a healthcare service equivalent, for clinical and documentary value, to an in-person visit
• Teleconsultation — remote consultation among two or more professionals on a specific case, with or without the patient
• Telereporting — remote reporting of diagnostic tests acquired elsewhere (teleradiology, telepathology, teledermatology)
• Telemonitoring — remote acquisition and transmission of vital parameters and clinical data from devices
• Teleassistance — remote health and social services for frail subjects

Outside a few consolidated experiences — teleradiology, telecardiology in regional chronic heart failure programmes, telemonitoring of diabetes — systematic adoption remained limited. Barriers were at once technical (uneven infrastructure), organisational (integration with records and FSE), economic (no harmonised tariffing for telematic services) and cultural.

The 2020 push

The SARS-CoV-2 pandemic shifted all these constraints at once. The need to reduce in-person contacts and to preserve continuity of care made telemedicine an operational tool, no longer an experiment. The main 2020 measures:

• ISS COVID-19 Report no. 12/2020 — Interim indications for paediatric telemedicine services during the COVID-19 emergency, March 2020, with subsequent extensions to other domains
• Ministry of Health Circular no. 13917 of 30 April 2020 — operational indications for telemedicine activities in the emergency phase
• Istituto Superiore di Sanità, COVID-19 Reports on telemedicine — a series of thematic reports (no. 60/2020 general, no. 12/2020 paediatrics, others on gastroenterology, psychiatry, neurological diseases)
• Decree-Law 19 May 2020, no. 34 (Decreto Rilancio) — provisions supporting telemedicine implementation in the NHS
• Regional guidelines — several Regions (Lombardy, Emilia-Romagna, Tuscany, Veneto, Piedmont, Lazio) produced operational acts regulating services, tariffing and organisational requirements

At the time of writing, the Ministry of Health and the State-Regions Conference are finalising new national indications for the delivery of telemedicine services expected by the end of 2020, updating and integrating the 2014 frame with pandemic experience.

The technical components of a telemedicine service

A concrete televisit or teleconsultation is a composition of distinct technical components:

• Real-time audio-video communication — typically via WebRTC (browser-based) or dedicated videoconference platforms. The vendor choice affects privacy, reliability, integration with reporting
• Patient and professional authentication — strong identity (SPID, CIE, CNS) vs. light identity (OTP codes); choice depends on clinical risk level and consent nature
• Informed consent — collected remotely, with double specification: consent to the telemedicine service and consent to data processing
• Clinical documentation produced — report, minutes, prescription; must be digitally signed and populate the FSE like any in-person service
• Recording and preservation — the audio-video recording, if performed, is itself health data and must be managed under GDPR; long-term preservation applies to the report, not necessarily to the recording
• Home devices — blood pressure monitors, glucose meters, pulse oximeters, portable ECG, connected via app/Bluetooth; raise issues of medical device qualification (MDR) and secure transmission of parameters

Useful standards

Unlike HL7 v2, CDA R2 and FHIR, telemedicine does not have a dedicated exchange standard of its own: it reuses and composes existing standards.

• FHIR provides the key resources: Encounter with class coded as virtual (VR), Communication for textual exchanges and notifications, Appointment for scheduling, DocumentReference for the report produced, Observation for parameters transmitted by telemonitoring devices, DeviceMetric for instrument configuration, MedicationRequest for downstream prescriptions
• IHE MHD (Mobile access to Health Documents) — IHE profile bringing XDS onto mobile interfaces, relevant for patient access to their documents
• HL7 FHIR Telehealth Implementation Guide (STU Draft, in preparation by HL7 International) — collects profiles, extensions and typical telemedicine scenarios
• Continua Design Guidelines — specifications of the Personal Connected Health Alliance for personal device integration, based on IEEE 11073 medical device profiles

On the infrastructure side, WebRTC (W3C + IETF RFC 8825) is the standard for browser audio-video transport, with end-to-end encryption via DTLS-SRTP. SIP (RFC 3261) remains common in integrated telephony infrastructures.

Open source

The open source telemedicine ecosystem received new attention in 2020:

• Jitsi Meet — open source WebRTC-based videoconference platform, used by several Italian healthcare institutions in the emergency phase as a self-hosted alternative to commercial providers. Can be deployed on-premise, integrating with the organisation’s authentication mechanisms
• BigBlueButton — open source e-learning platform with extensions for clinical webinars and teleconsultation
• Kamailio / Asterisk — open source SIP proxy and PBX, used in the VoIP architectures of some hospitals
• OpenMRS Telehealth Module — open source module for OpenMRS (EHR widespread in developing countries) to integrate televisits
• FHIR servers with telemedicine extensions: HAPI FHIR, Microsoft FHIR Server, IBM FHIR Server

Important distinctions: a generic videoconference platform is not, by itself, a telemedicine platform. A telemedicine platform adds consent management, digitally signed document production, service registry, record/FSE integration, access traceability.

GDPR and MDR requirements

Telemedicine carries reinforced GDPR obligations:

• Legal basis — art. 9(2)(h) for care purposes, identical to in-person services
• DPIA — typically required for the introduction of a telemedicine platform at enterprise scale, as systematic processing of health data at scale with new technologies
• Data processor — the platform provider is a processor under art. 28, with a detailed DPA contract
• Data localisation — infrastructural choices (public EU cloud vs. on-premise) have direct consequences on extra-EU transfers and on Schrems II requirements (CJEU judgment C-311/18 of July 2020 invalidating the Privacy Shield)

On the device side, Regulation (EU) 2017/745 (MDR), fully applicable from 26 May 2021, qualifies as medical devices both software platforms providing information for clinical decisions and home devices integrated into telemonitoring systems. The distinction between communication software (not a device) and diagnostic support software (device, at least Class IIa under Rule 11) is an important interpretive node.

Data and FSE integration

From the standpoint of data produced, a telemedicine service must be indistinguishable, in clinical documentation, from an in-person service. A televisit report is a document conforming to the Italian HL7 CDA R2 profiles — specialist visit record or equivalent — digitally signed, populated into the regional FSE through the same IHE XDS.b infrastructure used by other services.

Telemonitoring parameters pose a different challenge: they are continuous or semi-continuous streams of observations (blood pressure, blood glucose, saturation, heart rate, weight) generated at the patient’s home. Their systematic population into the FSE is not foreseen by the current document-centric model; the natural carrier is a FHIR API delivering Observations to territorial clinical records, with aggregation and summary in episode documents (e.g. a closure letter of the monitoring programme).

The trajectory

The accelerated adoption in 2020 is not a temporary episode: patients and professionals have acquired familiarity with remote modes in areas where there would be no going back (chronic disease, follow-up, mental health, palliative care). The next steps concern:

• Regulatory consolidation — the new national indications expected by end 2020 will harmonise tariffing, requirements and integration into care pathways
• Data standardisation — telemedicine-specific FHIR profiles in HL7 Italia’s work
• Device qualification — MDR conformity for home hardware, software platform certification
• FSE 2.0 integration — the announced FSE evolution will have to natively include telemedicine services

The theme connects closely to healthcare data in a broader sense — no longer only documents produced in hospital but streams generated in the patient’s daily life, requiring more granular and continuous exchange models than those adopted so far.

References: AGENAS — Telemedicina. Linee di indirizzo nazionali, State-Regions Conference 20 February 2014. ISS COVID-19 Reports no. 12/2020 and no. 60/2020 on telemedicine. Ministry of Health Circular no. 13917 of 30 April 2020. Decree-Law 19 May 2020, no. 34. Regulation (EU) 2017/745 (MDR). HL7 FHIR R4 — Encounter, Communication, Appointment, Observation resources. IHE MHD Profile. WebRTC (W3C/IETF RFC 8825). CJEU Judgment C-311/18 (Schrems II), 16 July 2020.