CIS system hazards derived from literature using systems and human factors perspectives
Bibliographic record
Abstract
The FDA and other national regulatory agencies have expressed their intentions to begin enforcement of medical device regulations on Health Informatics Technology (HIT) vendors. A mechanism which might be employed to achieve this enforcement in the US is the Quality Systems Regulations (QSR), while similar legislation might be employed elsewhere. In order for vendors to achieve conformance with QSR regulations, they must first identify hazards which their products may pose. In order to identify these hazards we have undertaken a literature review from which we have extracted taxonomies of Clinical Informatics Systems (CIS) devices, systems and hazards. We present these three taxonomies, and a discussion of contemporary risk classfication strategies which are being applied to HIT. The taxonomies which have been developed provide actionable hazards for HIT vendors, and provide a potential basis for best practices in the engineering of HIT systems.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.058 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.080 | 0.046 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.007 | 0.006 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".