Health Technology Assessment for In Silico Medicine: Social, Ethical and Legal Aspects

Abstract

The application of in silico medicine is constantly growing in the prevention, diagnosis, and treatment of diseases. These technologies allow us to support medical decisions and self-management and reduce, refine, and partially replace real studies of medical technologies. In silico medicine may challenge some key principles: transparency and fairness of data usage; data privacy and protection across platforms and systems; data availability and quality; data integration and interoperability; intellectual property; data sharing; equal accessibility for persons and populations. Several social, ethical, and legal issues may consequently arise from its adoption. In this work, we provide an overview of these issues along with some practical suggestions for their assessment from a health technology assessment perspective. We performed a narrative review with a search on MEDLINE/Pubmed, ISI Web of Knowledge, Scopus, and Google Scholar. The following key aspects emerge as general reflections with an impact on the operational level: cultural resistance, level of expertise of users, degree of patient involvement, infrastructural requirements, risks for health, respect of several patients’ rights, potential discriminations for access and use of the technology, and intellectual property of innovations. Our analysis shows that several challenges still need to be debated to allow in silico medicine to express all its potential in healthcare processes.

Supporting and Enabling the Process of Innovation in Public Health: The Framework for Public Health Innovation

“…They also illustrate dynamic properties in systems, and show how a problem is created and maintained over time [ 66 ]. In fact, innovation and sustainability require that issues are analyzed holistically, reflecting the health and social systems (e.g., social, ethical, and legal climate) that predict health innovations and programs, and by extension health outcomes [ 67 ].…”

“…Public health innovation must be framed around target population needs and holistic approaches [ 39 , 67 ]. Through the iTP3 project, the researchers found that programs developed by some organizations in the first cohort targeted underserved populations, but were not using youth feedback directly in the development process.…”

Human Factors and Organizational Issues: Contributions from 2022

“…The advent of major initiatives in in-silico medicine ('digital health') and particularly the use of AI-based tools also gives rise to many ethical and medico-legal issues. In [31], Leo et al discuss these and how they may be examined and addressed, using varied research methods across the range of stakeholders. The narrative review presents concepts without data, but calls attention to a range of ethical and potential legal issues including of computer simulation, the approach to enable the effective participation of patients and stakeholders in the decision-making process, the influence on the decision-making capacity of physicians and patients, the access to personal information, intellectual property issues, the balance of benefits and harms to patients, and the burden of a possible mistake in the simulation due to potential sources of bias leading to an incorrect definition of the algorithm.…”

Digital Twins and Healthcare: Quick Overview and Human-Centric Perspectives

“…However, Digital Twins also raise a series of questions that must be faced for introducing them in real contexts, pondering topics like technology acceptance [99]. Ethical issues are certainly among the problems that should be considered before planning the development of any technological solution in order to make it truly human-centric, especially when we consider situations requiring quick decision-making processes as in several healthcare procedures [61] and, in general, most precision medicine scenarios that are considered by HTA [100].…”