Table 1.

Summary of relevant ethical, legal, and social issues (ELSI) raised by digital technologies and health data processing in healthcare.

Digital health ELSI
Ethical
• Promotion of patient autonomy and empowerment
• Design, obtainment, and interpretation informed consent
• Identity confirmation and authentication
• Achieving fair distribution of risks, benefits, and costs
• Guaranteeing quality of care
• Strengthening the doctor–patient relationship
• Assuring continuity of care
• Defining professional duties and responsibilities
• Maintaining confidentiality
• Patient-generated health data
• Direct to consumer telemedicine and unsolicited requests for diagnosis and individual health management
• Dehumanization of care
• Moral status and ethical judgement of machines
• Human nature, quantified-self and technological singularity
Legal
• Appropriateness, coherence, and accessibility of regulation, including inconsistencies in interpretation by oversight bodies
• Assessment of validity, utility and quality of products, services, strategies, and interventions
• Data protection rights (including privacy by default, privacy by design, data destruction policies, the right to know and the right not to know)
• Data access, return of information and non-discrimination
• Data ownership rights, fair, transparent, and harmonized data sharing rules
• Compliance standards, oversight, and sanctions
• Broader data and device security issues
• Jurisdiction and licensure for telemedicine
Social
• Level of public participation and awareness
• Digital literacy levels of patients and health professionals
• Academic curricula adequacy (upgrades and updates)
• Limits to privacy and confidentiality in health
• Inequality and social stigma
• Lifestyle changes and adoption of healthy behaviors
• Impact on health access (economic, geographical, and informational)

Despite categorization, issues are mainly hybrid in nature.