Table 1

Moral claims of stakeholders and mitigation strategies

Moral claimDerived claims or potential solutions
 ConfidentialityData security measures and trustworthy data governance
 Informational self-determinationRight to govern/control/information/deletion/copy/correction
Right to decide about data use for ReuseForPro
 Patient involvement in governanceInvolve patient representative, for example, on data access and use committee
 Interest in clinical benefitReUseforPro is unlikely to generate direct clinical benefit to data donors—this should be clearly communicated in the informed consent process and this interest should not play an ethical role
 Share in profitsWeak claim, no ownership rights, data understood as public ressource
 Accountability and mitigation strategiesRisk minimisation must strive for compensation in the event of adverse consequences
For-profit companies in the health sector
 Freedom of researchCompanies are free in their choosing a research topic
 Access to patient dataContractual solutions; data access should be non-exclusive and non-discriminatory
 Sustainability on the marketProducts with added value in a field of high medical need justify high prices
Limits in the debate about fair pricing
 Corporate social responsibilityChecking carefully whether companies live up to what they promise
Publicand future patients
 Public benefitEnsure benefit outweighs risks and negative effects, for example, on public trust
 Trust in the healthcare systemFramework that ensures fair return and minimisation of risks
 Return to the healthcare systemMake sure return can be expected and will be monitored
 Effective competitionOversight that market access and effective competition is guaranteed for smaller and larger players equally
 Promotion of national companiesPromote companies that pay taxes or are trusted as long as it does not forestall effective competition
Healthcare institutions/physicians’ office
 Ownership of dataOnly extra investment in documentation for secondary use can substantiate claims—for refund or recognition
 Compensation for additional effortReimbursement of time, investment and personnel for additional efforts for documentation