Objective: The study analyzes the regulatory implications of digital technologies in Parkinson’s disease, with particular focus on (1) improvement of care and reduction of intensive care admissions, (2) personalization of treatment in progressive neurodegeneration, and (3) extension of safe home-based living to delay institutionalization.

Background: Digital health technologies offer significant potential across the PD continuum. Wearable, clothing-integrated, and ambient sensor systems enable continuous monitoring of a variety of PD symptoms in real-world environments. Smart medication systems may improve adherence to dopaminergic therapy and reduce “off” periods. Remote monitoring platforms facilitate tele-neurological assessment and earlier therapeutic adjustments, potentially preventing avoidable hospitalizations.

Machine learning applied to longitudinal datasets may support phenotypic stratification, early detection of progression, and personalized titration of pharmacologic and device-based therapies, including deep brain stimulation. Digital rehabilitation tools and cueing systems can promote sustained physical activity and neuroplasticity, helping to preserve mobility and quality of life. Collectively, these technologies may extend the period patients can safely remain at home while reducing caregiver burden.

Method: We conducted an international comparative analysis of regulatory and legal frameworks governing digital technologies in PD care, focusing on medical device approval, liability regimes, reimbursement structures, and data protection standards.

Results: Despite substantial clinical promise, several legal and ethical challenges persist. Key issues include: the allocation of liability in cases of device malfunction; inequitable access due to differences in reimbursement systems; ensuring meaningful informed consent, particularly in patients with cognitive impairment; safeguarding privacy and managing large-scale biometric datasets across jurisdictions; and integrating digital systems into established PD care pathways.

Conclusion: Digital technologies may substantially improve symptom control, enable personalized care, reduce preventable complications, and delay institutionalization in PD. However, harmonized regulatory standards, equitable reimbursement, transparent liability structures, and robust data governance are essential to ensure safe, responsible, and sustainable implementation in neurodegenerative care.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/digital-innovation-in-parkinsons-disease-governing-care-and-managing-autonomy/