Presented by Lisa-Jean Clifford, President, Gestalt
Introduction
The theme for the 2023 Pathology Informatics Summit Bootcamp was “Ethics, Equity, and Regulations.” The 2023 Summit Bootcamp theme advances the 2022 Summit Bootcamp theme, which was based on data analysis, data science, and data management.1
In the realm of ethics, the primary objectives are to maximize benefit and minimize harm while respecting patient autonomy and principles of just care. In the context of pathology informatics, professionals strive to use data to not only support the best care for patients but also to foster a sustainable work environment for labs and clinicians.
Equity deserves special attention in the context of lab data and the practice of lab informatics. Because diagnostic and monitoring testing form the core of much medical care, a vital role for pathology informatics as a profession is to ensure that lab testing data are equitably utilizable for clinical decision-making, research, and technological advancements.
Finally, the lab is one of the most heavily regulated areas of medical practice.2 Federal, state, and institutional data regulatory requirements are applicable to lab and pathology operational processes and the data they produce.
The Bootcamp format comprises eight sessions featuring 40-min talks delivered by experts on each topic, followed by a question and answer session. The topics covered in the Bootcamp align with Pathology Informatics, Education, and Research (PIER)3 content, as outlined in Table 1.
Session: Data Use in Digital Pathology
Presented by Lisa-Jean Clifford
Session Content
- Develop understanding of how pathological information takes many forms and formats, and one approach will not fit all needs
- Recognize different incentives and stakeholders around data use
- Understand the nuances of disparate data uses –Lab, Academia, Research, and consider how ethics principles may be applied to each
PIER Mapping
- Essentials 1-Topic 4: Data availability and security
- Essentials 4- Topic 2: Lab data analytics for quality improvement, education, and research
Summary Notes
This session highlighted the need for interoperable digital pathology solutions to facilitate widespread implementation and adoption.
Ms. Clifford explained that an interoperable digital pathology solution enabled access to diverse and specific data from various sources, including patient data, specimen information, image metadata, case details, diagnostic information, physician information, and turnaround times. These data can be aggregated, tagged, grouped, reported, segmented, searched, and applied across different functional areas and for a variety of uses.
The uniqueness and identifiability of each piece of data allow for both personalized insights and de-identification for statistical purposes. Such datasets encompass geographic and demographic information and are utilized in the healthcare setting for precision medicine, clinical trials, drug trials, and academic and research settings for teaching and product development.
Metadata plays a crucial role in associating data with digital images, AI algorithm tracking, tumor grading, scoring, tissue types, diagnosis, and more. This metadata is instrumental in determining treatment effectiveness, identifying abnormalities or mutations, and predicting patient responses to specific treatments.
Ms. Clifford explained that the data usage policies varied across healthcare facilities and addressed the availability of de-identified data for commercial or non-commercial purposes and the requirement for patient approval. Patients may have access to their own data, including de-identified or disease-related trends, raising considerations for equity and access to healthcare information.
Conclusions
The 2023 Pathology Informatics Summit Bootcamp provided an in-depth exploration of the intersection of ethics, equity, and regulations in the field of pathology informatics. Participants gained insights into the critical roles these elements play in lab data workflows and patient care. The Bootcamp underscored the need for ongoing consideration of these themes in pathology informatics to ensure ethical use of data in the pursuit of optimal patient care, equitable utilization of lab testing data, and meaningful interpretation of regulatory requirements.
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