RESUMEN

The Health Level 7 (HL7) organization introduced the Information Sensitivity Policy Value Set with 45 sensitive data categories to facilitate the implementation of granular electronic consent technology. The goal is to allow patients to have control over the sharing of their sensitive medical records. This study represents the first attempt to explore physicians' viewpoints on these categories. Twelve physicians participated in a survey, leading to revisions in 21 HL7 categories. They later classified 600 clinical data items through a second survey using the updated categories. Participants' perspectives were documented, and data analysis included descriptive measures and heat maps. In the first survey, six participants suggested adding 19 new categories (e.g., personality disorder), and modifying 25 category definitions. Two new categories and sixteen revised category definitions were incorporated to support more patient-friendly content and inclusive language. Fifteen new category recommendations were addressed through a revision of category definitions (e.g., personality disorder described as a behavioral health condition). In the second survey, data categorizations led to recommendations for more categories from ten participants. Future revisions of the HL7 categories should incorporate physicians' viewpoints, validate the categories using patient data or/and include patients' perspectives, and develop patient-centric category specifications.

RESUMEN

The European Union implemented data privacy laws in mid-2018 and the state of California enacted a similar law several weeks later. These regulations affect medical data collection and analysis. It is unclear if they achieve this goal in the realm of clinical trials. Here we investigate the effect of these laws on clinical trials through analysis of clinical trials recorded on the US's ClinicalTrials.gov, the World Health Organization's International Clinical Trials Registry Platform and scientific papers describing clinical trials. Our findings show that the number of phase 1 and 2 trials in countries not adhering to these data privacy laws rose significantly after implementation of these laws. The largest rise occurred in countries which are less free, as indicated by the negative correlation (-0.48, p = 0.008) between the civil liberties freedom score of countries and the increase in the number of trials. This trend was not observed in countries adhering to data privacy laws nor in the paper publication record. The rise was larger (and statistically significant) among industry funded trials and interventional trials. Thus, the implementation of data privacy laws is associated a change in the location of clinical trials, which are currently executed more often in countries where people have fewer protections for their data.

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Psychiatric research traditionally relies on subjective observation, which is time-consuming and labor-intensive. The widespread use of digital devices, such as smartphones and wearables, enables the collection and use of vast amounts of user-generated data as "digital biomarkers." These tools may also support increased participation of psychiatric patients in research and, as a result, the production of research results that are meaningful to them. However, sharing mental health data and research results may expose patients to discrimination and stigma risks, thus discouraging participation. To earn and maintain participants' trust, the first essential requirement is to implement an appropriate data governance system with a clear and transparent allocation of data protection duties and responsibilities among the actors involved in the process. These include sponsors, investigators, operators of digital tools, as well as healthcare service providers and biobanks/databanks. While previous works have proposed practical solutions to this end, there is a lack of consideration of positive data protection law issues in the extant literature. To start filling this gap, this paper discusses the GDPR legal qualifications of controller, processor, and joint controllers in the complex ecosystem unfolded by the integration of digital biomarkers in psychiatric research, considering their implications and proposing some general practical recommendations.

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Uterus Transplantation (UTx) is an experimental vascular composite allograft designed to provide women with absolute uterine factor infertility with the opportunity to gestate and give birth to their future offspring. The number of UTx procedures performed worldwide now stands at ≥70 and as the number of cases performed increases so too does the volume of potential data that may be gathered to inform the development, practice and regulation of UTx. Given the value of this data, and the challenges associated with keeping track of cases and outcomes where data remains unpublished and/or scattered, scientists and academics conducting research into UTx have increasingly called for the swift creation, implementation and management of an international registry for Uterus Transplantation (IRUTx). This article explores and provides practical guidance regarding the potential benefits the IRUTx may provide to stakeholders, as well as the legal and ethical challenges that its creation may pose in terms of dataset design, consent, privacy, researcher compliance and governance.

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RESUMEN

Recently, the US Food and Drug Administration has given a landmark approval to the very first digital pill with a sensor embedded in the inside. These are complex systems that include a drug and an electronic tracker that is activated when the patient takes the pill. Accordingly, they might be an excellent tool for monitoring and potentially improving patients' adherence to prescriptions. This would serve well to avoid unnecessary healthcare costs and reduce the anxiety of patients and their relatives. However, digital pills might also diminish patient autonomy, reduce privacy, or promote inadequate use of pharmaceutical resources. This article is aimed at contributing to adequate use of this new tool by showing the main ethical and social issues they involve and proposing measures meant to address them. Finally, we conclude by defending the idea that these new systems should be seen as means of complementing traditional strategies to promote adherence to treatment, and not as substitutes.