“I Agree to Disagree”: Comparative Ethical and Legal Analysis of Big Data and Genomics for Privacy, Consent, and Ownership
Review Article
Seema Belani, Georgina C. Tiarks, Neil Mookerjee, Vijay Rajput
Cureus, 13 October 2021
Abstract
Statement of Purpose
Digital healthcare, as it relates to big data and genomics, presents a real threat to privacy and ownership rights for individuals and society.
Research Question/Hypothesis
Our experience with genomics provides a lens to facilitate the way we navigate toward a future health data space. Contemporary and innovative legal and ethical models can be applied to concepts of privacy, ownership, and consent in relation to big data.
Significance
Technological innovation has transformed healthcare at a faster rate than legal reform, security measures, and consent policies can adapt. The Health Information Portability and Accountability Act (HIPAA) has been recognized as a work in progress, with respect to big data as it relates to healthcare and individual wellbeing. The shortcomings of HIPAA, and its application to big data, can be paralleled with its prior limitations surrounding genomics in the last two decades. The Genetic Information and Nondiscrimination Act (2008) and Genomic Data Sharing Policy (2015) were established to overcome HIPAA’s inadequacies concerning genetic discrimination and security. These policies can serve as a basic model for our approach to legislative reform as it relates to privacy risks with big data generated in healthcare and from healthy individuals in society who are not patients. In addition to notions of privacy, concepts of ownership and consent have become increasingly vague and opaque. The technological advancements have facilitated access and transmission of information, such that big data can be sold for financial gain for commercial enterprise. This applies to genomics, with companies like 23andMe, in addition to big data, as it relates to big tech giants like Apple or Google who oversee wearable and search term data. Clarity of ownership within a digital healthcare arena needs to be defined through ethical and legal frameworks at a global level.
Approach
A narrative review of the literature published between 2010 and 2021 was performed using PubMed and Google Scholar. Articles discussing privacy, security, ownership, big data, and genomics were included as relevant literature.
Importance
As a society, we are at a crossroads; we must determine the extent of privacy that we are willing to give for science and society. We cannot continue with the current status quo in hope that individual will be used for the greater good of society. We need to strive for a cohesive approach to combat privacy violations by encouraging legislative reform, ethical accountability, and individual responsibility.

Learning from informed consent litigation to improve practices: A systematic review
Karine Giudici-Wach, Pierre Gillois, Thomas Remen, Frédérique Claudot
Patient Education and Counseling, 8 October 2021
Abstract
Objective
To describe the reasons that lead judges to qualify malpractice as a lack of information, then rule in favour or not of the health professional (HP).
Methods
We conducted a systematic review of case law relating to the breach of disclosure obligations over a ten-year period from 2010 to 2020. We used 3 legal databases: Légifrance, Dalloz and Lexis 360, all identified as the most exhaustive.
Results
Of the 514 law cases included: judges found malpractice owing to lack of information in 377 (73.3%) cases. Among the latter, malpractices were lack of risk information (N = 257, 68.2%), lack of proof of information (N = 243, 64.5%) and/or lack of information on therapeutic alternatives (N = 49, 13.0%). These malpractices resulted in a conviction of the HP in 268 (71.1%) of the cases.
Conclusion
Case law is an important source of information for improving the quality of HP, lawyers, and judges’ practices.

The Informed Consent Doctrine in Legal Malpractice Law
Vincent R. Johnson
St. Mary’s Journal on Legal Malpractice & Ethics, 6 October 2021; 11(2)
Open Access
Abstract
The doctrine of informed consent is now deeply embedded into the law of legal ethics. In legal malpractice litigation, the doctrine holds that a lawyer has a duty to disclose to a client material information about the risks and alternatives associated with a course of action. A lawyer who fails to make such required disclosures and fails to obtain informed consent is negligent, regardless of whether the lawyer otherwise exercises care in representing a client. If such negligent nondisclosures cause damages, the lawyer can be held accountable for the client’s losses. Shifting the focus of a legal malpractice action from garden-variety negligence (such as ignorance of the law, late filing of a complaint, or failure to safeguard client funds or data) to a lack of informed consent can potentially transform a losing case into a winner. Among other things, the doctrine has the potential to simplify and clarify the plaintiff’s argument, which may be especially useful if the case is tried to a jury. The informed consent doctrine also makes sense as a matter of public policy, because clients have a right to control important matters related to their representation. This Article explores the informed consent doctrine in legal malpractice law. It discusses the rise of the informed consent doctrine in medical malpractice law and traces the transplantation of the language and principles of informed consent, first, into the law of lawyer discipline, and then into the law of lawyer civil liability. The Article explores what the relevant legal malpractice case law says about the obligation to obtain informed consent. Finally, the Article addresses certain pivotal issues in the operation of the informed consent doctrine in claims by clients against lawyers, including the nature of lawyer disclosure obligations, the limits imposed by the scope of the representation, the role of expert testimony, and the standard for proving factual causation.

Risk Management for a Legally Valid Informed Consent
Guerra F, La Rosa P, Guerra F, Raimondi L, Marinozzi S, Miatto I, Vergati D, Ndokaj A, Gasperini N, Corridore D, Nardi GM, Mazur M, La Torre G, Ottolenghi L
La Clinica Terapeutica, 1 September 2021; 172(5) pp 484-488
Abstract
Gelli-Bianco law (Law no. 24/2017) [Italy] intervenes both in order to divide healthcare liability between the healthcare professional and the facility in which he/she exercises and to incentivize the latter to adopt an organizational model suitable for managing the risk associated with the provision of any healthcare service, including the information for consent. In fact, the healthcare facility must guarantee clear, complete and adequate information on the specific case, which, therefore, cannot consist of standard forms to be signed by the patient, under penalty of a flawed consent to treatment and consequent healthcare liability in the event of an adverse event. The regulation mandates that safety must be guaranteed through proper prevention tools and health care risk management, in conjunction with the most effective use of structural, technological and organizational resources available. It further spells out the obligation of health care professionals to contribute to risk prevention while administering health care procedures. For this reason, the consent information constitutes a source of risk for the responsibility of the healthcare provider and the Facility and it must necessarily be managed. Risk Management is the management tool that can allow the healthcare facility to improve the quality and safety of the services provided, optimizing the risk of adverse events through proper monitoring of the same. This paper will be published, following a special agreement, on the two journals “Igiene e Sanità Pubblica” and “La Clinica Terapeutica”, in Italian and in English, in order to increase the diffusion to a wider audience.