STATE REGULATION OF DIGITAL ACCESSIBILITY OF HEALTHCARE SOFTWARE

Abstract

Introduction. Digital health services can expand access to care, yet an inaccessible interface, authentication method, consent form, or telehealth channel may interrupt the patient journey. For a person with a disability, this may cause delayed care, loss of autonomy or confidentiality, and discontinuity of treatment. Purpose. To substantiate a risk-based model for state regulation of the development and use of healthcare software that ensures accessibility of the end-to-end digital patient journey and links regulatory intensity to the consequences of an inaccessible function. Materials and Methods. The study applies systemic, institutional, comparative legal, human-centred and risk-based approaches. It analyses Ukrainian legislation and strategies on eHealth, telemedicine, accessibility, medical devices and data protection; the UN disability convention; WHO and ITU documents; EN 301 549, WCAG 2.2, relevant EU acts, and research published in 2022–2025. Results. The proposed regulatory circuit combines a digital health service passport, risk class, accessibility profile, technical specification, co-design, combined testing, acceptance, and incident monitoring. Three levels are distinguished: informational-supportive, administratively significant, and clinically or life critical. The model sets requirements for telehealth, authentication, consent, representation, assistive technologies, algorithmic functions, and continuity of care. State control should assess completion of a critical scenario in a specific system version rather than only an interface conformance declaration. Prospects. Phased implementation should include a digital health service passport, a national eHealth accessibility profile, a digital-barrier risk matrix, acceptance evidence packages, an incident register, and patient-journey indicators. Initial pilots should cover primary-care booking, e-prescriptions, telehealth and the patient portal, with participation of persons with diverse disabilities. Pilot results should support subsequent refinement of regulatory requirements.