Digital health is the set of technologies that digitise data, diagnosis and medical care: electronic health records, AI-assisted diagnostics, telemedicine and wearable devices for continuous monitoring. 2026 is a year of concrete deadlines more than announcements: Italy is working towards national interoperability of its electronic health record, Europe has set its common health-data space in motion, and AI-assisted diagnostics has for the first time passed one thousand authorisations in the United States.
Contents
- What digital health is
- Electronic Health Record 2.0: status in Italy
- The European Health Data Space (EHDS)
- AI diagnostics: where it actually works
- Telemedicine: what is reimbursed and what isn’t
- Wearables and continuous monitoring
- Digital mental health: apps and their limits
- The AI Act and high-risk medical devices
- Privacy and cybersecurity of health data
- FAQ and healthcare in 2035
What digital health is (definition)
Digital health is the application of information technology, artificial intelligence and connected devices to four areas of medicine: managing clinical data, diagnosis, remote delivery of care, and continuous monitoring of health status. It does not replace the doctor-patient relationship, but changes its informational support: more complete, shared data that, increasingly, is also analysed by AI systems as a second opinion.
Electronic Health Record 2.0: status in Italy
The Electronic Health Record (Fascicolo Sanitario Elettronico, FSE) is the digital container that gathers every citizen’s clinical history: reports, discharge letters, prescriptions, and the new Synthetic Health Profile compiled by the treating physician. It has existed since 2012, but the original version was deeply inconsistent across Italy’s regions, to the point that a patient moving from one region to another often had to start from scratch.
The status verified as of August 2026: the implementing decree set 31 March 2026 as the deadline for stricter rules to take effect, which for the first time extend the obligation to feed the record to outpatient clinics, dental practices and private laboratories, not just public facilities, with documents to be uploaded within 5 days of the service being provided. The stated target for full national interoperability across all regions is June 2026, though several industry sources flag a real risk of further regional slippage: some regions, such as Tuscany, have already obtained local extensions on specific technical points. Citizens retain control over their data through a masking right (they can hide individual documents from specific professionals) and can check at any time who has accessed their record and for what purpose.
The European Health Data Space (EHDS)
EHDS (the European Health Data Space) is the EU regulation, in force since 26 March 2025, that builds a common framework for sharing health data between member states, both for direct-care purposes (primary use) and for research and health-policy purposes (secondary use).
| Deadline | What happens |
| 26 March 2027 | General application of the regulation; core obligations for electronic health record providers |
| 26 March 2029 | Exchange of the first priority data categories (synthetic health profile, e-prescriptions) between all member states, and secondary-use rules start applying to most data |
| 26 March 2031 | Extension to the exchange of medical imaging, lab results and hospital discharge letters |
For Italy, the natural link is with the FSE 2.0 infrastructure, which will need to become compatible with the European interoperability standards (such as the FHIR format) required by EHDS.
AI diagnostics: where it actually works
In the United States, the FDA passed 1,300 cumulative authorisations for AI-based medical devices in 2026, with radiology alone accounting for around 76% of all authorisations; 258 were granted in 2025 alone, a record year. A representative case is Aidoc, which secured authorisation for an AI triage solution combining eleven new clinical indications with three already authorised, reaching in its registrational studies an average sensitivity of up to 98.5% and specificity of up to 99.7%.
The flip side, documented in an analysis published in npj Digital Medicine, is transparency: almost half of FDA summaries for authorised devices do not describe the clinical study design used for approval, and more than half omit sample size, making it hard for doctors and hospitals to genuinely assess how reliable a given tool will be in their own specific clinical context. The right message for readers: AI diagnostics works well on specific, narrow tasks (spotting a fracture, flagging a suspicious nodule), not as a general substitute for medical judgement.
Telemedicine: what is reimbursed and what isn’t
Telemedicine covers remote visits, remote monitoring of clinical parameters, and teleconsultations between specialists. In Italy, reimbursement by the National Health Service remains uneven across regions and across services: some follow-up teleconsultations are treated the same as an ordinary outpatient visit for co-payment purposes, while other remote-monitoring services remain tied to specific regional projects, often funded through the PNRR recovery plan, with no single national tariff. FSE 2.0 now includes dedicated functionality for telemedicine services, a sign of the direction the system is converging on.
Wearables and continuous monitoring
Smartwatches and smart rings today offer certified clinical functions in some markets (such as atrial fibrillation detection) alongside generic wellness metrics (sleep, stress, recovery) that do not carry the same level of medical validation. The practical distinction for readers: a function carrying medical-device certification has passed a verifiable regulatory pathway; a “readiness” or “stress” score generated by a proprietary algorithm has not, and should be treated as a wellness indicator, not clinical data.
Digital mental health: apps and their limits
Mental health support apps, often built around conversational chatbots, have seen rapid growth in downloads and use. The scientific community remains divided on their effectiveness as a standalone tool: most available studies place them as a complement to a therapy path led by a professional, not a substitute for therapy in cases of significant psychological distress. The right tone for this section is cautious: highlighting easier access without downplaying the limits in serious clinical situations.
The AI Act and high-risk medical devices
The EU’s AI Act, in force since August 2024, classifies AI-based medical devices as “high-risk” systems, with reinforced obligations around risk management, training-data quality and human oversight. Most obligations for high-risk AI take effect from August 2026, with full compliance for AI medical devices required by August 2027: a manufacturer placing an AI-based diagnostic tool on the EU market today already has to navigate this double regulatory track, the AI Act plus the medical device regulation (MDR).
Privacy and cybersecurity of health data
Health data remains among the most sensitive categories of personal data, and among the most targeted by cyberattacks, precisely because of its black-market value and the operational impact a systems shutdown has on a hospital. EHDS imposes security and access-tracking requirements for electronic health record systems, but the operational responsibility for implementing them still rests with each individual healthcare facility, with very different maturity levels between large hospitals and small private practices.
FAQ
Is the Electronic Health Record already complete across Italy?
Not entirely yet: the stated target for full national interoperability is June 2026, but some regions have obtained local extensions on specific technical points.
What is EHDS and does it affect ordinary citizens?
It’s the EU regulation on health data: it affects citizens mainly through rights of access and control over their own data, with the first concrete cross-border exchange features expected by March 2029.
Can an AI replace a doctor’s diagnosis?
No: even the most widely authorised AI devices (over 1,300 in the US) are validated for specific, narrow tasks, not as a general substitute for clinical judgement, and remain supervised by a professional.
Can my smartwatch really detect a heart problem?
Some specific functions, such as atrial fibrillation detection, have recognised clinical validation in several markets; other metrics like stress or recovery remain wellness indicators, not diagnostic data.
Do mental health apps replace therapy?
In most available studies, no: they are generally positioned as a complement to a therapy path with a professional, not a substitute in cases of significant distress.
Healthcare in 2035
If health-data interoperability, in Italy and across Europe, genuinely reaches the maturity promised by today’s regulatory deadlines, medicine in the next decade could rest on an unprecedented shared information base: clinical data that follows the patient anywhere in Europe, increasingly specialised but transparent AI diagnostic systems, and a clearer line between what a wearable device can actually certify and what remains a wellness indicator. The open question is whether the technical infrastructure will keep pace with the regulatory deadlines, or whether, as already happened with the FSE, regional slippage becomes the norm rather than the exception.
Sources
- Italian Ministry of Health, implementing decree on Electronic Health Record 2.0
- European Commission, European Health Data Space (EHDS) regulation
- FDA (Food and Drug Administration), data on AI-based medical device authorisations
- npj Digital Medicine, analysis of transparency in FDA summaries for AI devices
- Aidoc, data on its own AI triage system’s registrational studies
- EU Artificial Intelligence Act (AI Act)
