Medical confidentiality

Patients have a legitimate expectation in a trusting relationship with their physicians. This trust is based on the quality of their physicians’ care, their commitment to the patients’ best interest as a priority goal, and to a relevant degree on the physician keeping personal information confidential.32,iv The patient’s right to confidentiality is firmly established in medical ethics and law. With ReuseForPro, medical confidentiality is affected if medical data that leave the protected realm of the patient–physician relationship is not adequately protected from unauthorised access and reidentification. In general, deidentification is a pivotal measure for protecting confidentiality. Technical safeguards including secure access mechanisms (see ‘Basic concepts and definitions ’) may add additional layers of protection against reidentification.

Informational self-determination

As referred to in the section ‘Basic normative principles for ethical assessment of involvement of private companies’, one of the relevant basic rights is the moral right to privacy and informational self-determination. We conceive the right to informational self-determination as follows: ‘The right to informational self-determination protects a person’s ability to freely decide whether and how personal data and information about her are collected, stored, multiplied, processed and transferred by third parties […]. In the following, we use the term informational self-determination instead of (informational) privacy for it better captures that the right is about actively determining what happens with one’s personal data and information.’33 This right becomes particularly important when it comes to highly sensitive medical data.

Representation and patient involvement

Out of a wish to govern the use of their data, patients might expect to be included in decision-making bodies of data initiatives. Such a form of participation is already being realised in some places through patient representatives on data access and use committees. This claim is substantiated by the principle of representation. Furthermore, involving patients has the potential to foster trust in the governance of data and improve the quality of oversight.

Interest in clinical benefit

In research activities such as phase III clinical trials where patients potentially gain a clinical benefit, the interest of participating patients in this clinical benefit is a valid moral claim to be factored into the overall ethical assessment of a study. In other research activities, it is highly unlikely that participating patients will benefit, so that appropriate information is required to avoid false hopes and therapeutic misconception. We assume that ReuseForPro is highly unlikely to generate clinical benefit for data donating patients due to the lengthy development and approval process for new therapies or medical products. Therefore, individual clinical benefit should play no role in the ethical assessment of ReuseForPro. The envisaged benefit of ReuseForPro is for future patients and the public (discussed in the section ‘The public an future patients’).

Share in profits

Patients might claim a right to a share in the profits of commercial success of products developed with their medical data. To make that claim, patients could refer either to the principle ‘to each person according to her effort’ or ‘to each person according to her contribution’34 as a principle of justice for the sharing of profit. However, we doubt that either claim can substantiate a case for patients’ right to have a share in profits from commercial success of products from ReuseForPro. As far as additional effort is concerned, medical data are traditionally generated by doctors and other specialists using the resources and infrastructure of the public health system as part of the individual care of patients. For patients, ReuseForPro creates little or no relevant extra effort, work, or investment other than the time during the information and consent process to decide whether or not to allow access to their diagnosis and treatment data when asked. The data are just a first level of effort in the highly complex, long and resource-intensive process of developing a successful medical product that requires significant efforts by the company.

The contribution principle emphasises that patients’ medical data are as a matter of fact—and completely independently from any effort, labour or investment—an indispensable contribution for the development of a profitable product based on ReuseForPro. Hence, patients can legitimately say that they contribute to data collection and that they want a share in the profits in proportion to their admittedly small contribution. Here, we would first point out that the data themselves and even new scientific insights do not typically generate profit directly. More importantly, we would argue along with other scholars35–37 that these medical data should be a public resource, for the following reasons. The data themselves are generated in a publicly funded health system. The public and tax-payer investment in the healthcare infrastructure including the training and education of staff and the payment for diagnostics and therapies justify a claim on using them for public benefit. Hence, while medical data certainly fall under patients’ control required by the right to informational self-determination, patient ownership rights cannot necessarily be deduced.

Accountability and liability

Patients are entitled to clear accountability structures and compensation in the event of adverse consequences from ReuseForPro, a claim based on our principle of accountability and liability described above. Harm mitigation bodies have been suggested by some scholars for situations where data subjects experience harms arising from digital data use in the big data context.38 While this suggestion is convincing in principle, the challenge lies in the implementation—that is, how exactly to demonstrate harm caused by ReuseForPro that may result from, for example, privacy breaches or negative ratings by predictive analytics. Provisions for either legal remedies or harm mitigation are, however, specific to neither the distinction between academic and for-profit data initiatives nor for healthcare or other economic sectors.

Freedom of research and right to access patient data

For-profit companies in the health sector are entitled to freedom of research. Freedom of research is primarily a defensive right that restricts the influence of state institutions on research activities, among other things, to the extent that researchers, and thus also private company researchers, are free to decide on their choice of research subject. Going beyond the defensive function, for-profit companies might additionally claim that the fundamental right to freedom of research constitutes a right to access patient data stored in publicly sponsored data sharing infrastructures. In fact, research-based pharmaceutical companies have repeatedly criticised that they are not given access rights to patient data, for example, under the Patient Data Protection Act in Germany.39 However, it is not clear how freedom of research, as a defensive right, can substantiate a claim for access to medical records of patients stored in publicly funded infrastructures. For-profit companies might even have an interest in exclusively accessing real-world patient data for their research to keep competitors at arm’s length. However, exclusive access40 would restrict rather than stimulate competition—which would tend to be in the interest of the company but not the interest of the greater public. What private companies can legitimately demand is a fair playing field so that there are equal and fair conditions of access for all companies alike. So, in principle, any data access provided to the private sector should be non-exclusive and non-discriminatory.v

Profitability

Certainly, private companies in the healthcare sector have a legitimate interest to generate profits and thrive on the market. The ideal way to achieve this goal is to develop high-quality products that generate real added value and address a need in an area with a high burden of disease. For these kinds of innovations societies are willing to pay high prices. While high market profits are in the company’s interest, two ethical debates are connected to the pricing strategies of pharmaceutical companies: first, whether it is legitimate to demand the highest possible price that the market allows if this puts the respective healthcare systems under great financial pressure. And second, whether pharmaceutical companies have ethical obligations to charge fair prices for essential medicines. These debates are particularly relevant for products developed with data from patients and from a publicly funded healthcare system. While companies have a legitimate right to pursue and realise profits, in the case of ReuseForPro particular restrictions to this right are justified if necessary to safeguard social benefit of ReuseForPro.41

Corporate (social) responsibility

Corporate responsibility implies to take on social responsibility beyond the companies’ actual business purpose and is an expectation of society vis à vis private companies. At the same time, the formulation of a corporate social responsibility (CSR) strategy and the corresponding activities are generally also intended to improve the company’s image. In our context, companies working with patient data have an interest in CSR ideally out of a felt duty to protect patients’ privacy or generate value for society and certainly in order to build trust in their business model. This amalgamation of two goals—real assumption of responsibility and image cultivation—makes it necessary to check carefully whether companies live up to what they promise. Especially in the new field of AI development, concrete expectations towards corporate responsibilities of companies in developing new AI products are being formulated e.g., with a list of criteria for trustworthy AI of the European AI Alliance42 or the Montreal declaration for responsible AI.43

Public benefit

The public and prospective patients have an interest in ReuseForPro as it has high potential to benefit society.44 A strong orientation towards the public benefit (common good) is critical for public acceptance and trust concerning ReUseForPro,10 and essential for its moral justification. Research with patient data generated through everyday healthcare encounters could promote drug safety for patients, make clinical trials more efficient, substitute placebo controls by so-called virtual control arms with existing patient data and increase the quality and cost-effectiveness of the health system with AI tools, for example, for decision support. Since pharmaceutical and biotech companies make for a significant proportion of research and development in the health sector, there are good reasons to assume that ReuseForPro will exploit the potential of medical data along a spectrum from high public benefit in post-market surveillance data to potential long-term benefits when used for research and development.

Return to the healthcare system

The public has a morally legitimate interest to receive a return from private entities for providing them with the opportunity to use patient data for secondary research purposes. This return can take many different forms that contribute to the maintenance and improvement of the healthcare system: increase of scientific medical knowledge; medical products that help improve the prevention, diagnosis or care of disease at a reasonable cost; or fees for data access that can be reinvested in healthcare.45

Trust in the healthcare system

The public has an interest in ensuring that citizens and patients trust the public healthcare system and its institutions. Empirical studies show that the acceptance of the use of data by commercial users is significantly lower than acceptance of data use by academic users (see ‘Introduction’). ReuseForPro is a publicly and politically delicate endeavour and has the potential to seriously compromise public trust.10

Effective competition

The public has a legitimate interest in ensuring that ReuseForPro is consistent with effective market competition and does not exacerbate existing imbalances in the market due to accumulated market power of individual companies. Effective competition including global competition involves preventing the formation of monopolies and oligopolies. Access to patients’ data for big players like Amazon or Alphabet (google) in ReuseForPro, as, for instance, in the case of NHS, could reinforce existing monopolies, and therefore, needs to be handled and regulated with particular attention and caution.

Promotion of national companies

If we conceive the public as the people of a state, the public has an interest in timely access to high-quality healthcare products, which is promoted by competition nationally and globally. The public might also have a special interest in promoting national companies or, in the case of EU members, at least companies of the EU if research and development take place ‘at home’ and taxes are paid within the state. National companies might also be perceived as more trustworthy in the public opinion and can be held accountable within the national jurisdiction. These reasons might serve as a weak argument for granting preferred access to national companies. However, data are not a limited resource since they are reproducible and such preferred access must not forestall effective competition.

Ownership of health data

Physicians might claim that the data only exist because they collected and documented them, and therefore, they own their patients’ data. Likewise, hospital managers and the institution could claim that it is their stewardship of resources and governance that ensures functionality of the healthcare delivery in their institution and data collection is an important element of this and therefore the data belongs to the hospital. From these ownership claims, physicians and hospital managers could derive an entitlement to deny data use by private companies, or to condition such access on a share in the eventual profits. However, data ownership claims of physicians and hospitals are problematic. First and foremost, the concept of data ownership of second parties itself conflicts with patients’ right to informational self-determination. Second, medical data are not generated as an end in itself but as part of physicians’ primary task to provide state of the art healthcare. Third, actors such as technicians (eg, in connection with MRI) or laboratory staff also produce a relevant part of the data and would therefore also have a (partial) claim to data ownership. Fourth, with regard to the ownership claims of hospital management, most of the resources used for diagnostics and thus for data generation are financed with public money. The argument from the resources invested in data generation thus argues, if anything, for ownership claims on the part of society, with hospitals playing an important role as responsible stewards of this resource. However, to the extent to which ReuseForPro is associated with additional burdens, efforts and costs for hospitals or physicians, they have certain legitimate claims for compensation or reward for these additional efforts (see next section ‘Compensation for additional effort’).

Compensation for additional effort

Contrary to popular belief, the data are not just there as a treasure waiting to be exploited. To make the data usable, they must be documented in a uniform and structured manner and their context of origin must be annotated with sufficient accuracy in metadata.46 This is associated with relevant additional data work, which does not necessarily have to be carried out by the physicians themselves. Especially since physicians today rightfully complain that they spend more and more time on documentation and data entry at the expense of time with the patient, it is important to see that additional standardisation and documentation are usually required to make the data usable for ReuseForPro. Hence, healthcare providers and individual physicians contributing data for ReuseForPro have a legitimate claim to be relieved from or compensated for any additional efforts for data procurement and documentation—meaning any extra effort beyond what they are obliged to do for ensuring quality patient care.

Interest in exclusive research with ‘own’ patient data

Healthcare institutions and physicians with academic affiliation might be interested in research with patient data themselves, especially if they have an academic mandate to do so. They might also team up with for-profit companies for joint research projects that may also lead to commercial outputs. Since data can be duplicated and are, therefore, a non-rivalrous resource for health research, access should be non-discriminatory meaning that academic researchers and private sector health researchers should have equal access to the data if a return to the healthcare system is secured and if patients have consented to ReuseForPro. If the data-requesting company pursues a research goal similar to that of an internal academic research project, there might be a situation of competition between the company on the one hand and the academic researchers or hospital on the other hand. Should this be the case, clear rules based on public value and patients’ consent to reuse data by academic and commercially oriented researchers are pivotal.

Table 1 maps potential claims of stakeholders, weighs them tentatively according to the ethical assessment and lists strategies for mitigating tensions between claims.