PhysioCompliance: evidence, privacy, and lifecycle controls

Deterministic SHA-256 audit chains and externally authenticated electronic signatures, explicit de-identification policies, keyed pseudonymization, structured header scrubbing, and plan-first data-subject helpers for PhysioExperiment::PhysioExperiment records. The package also supplies original lifecycle/risk templates, deterministic traceability graphs with objective-evidence hashing, and read-only package engineering-readiness checks.

Details

PhysioCompliance provides compliance-supporting technical controls. It does not determine device status, assign a software safety class, decide risk acceptability, authorize release, or certify conformity with HIPAA, GDPR, 21 CFR Part 11, IEC 62304, ISO 14971, an FDA guidance, a quality-system regulation, or a Bioconductor policy. A regulated deployment also requires qualified review, validated systems, access controls, identity proofing, credential lifecycle management, policies, training, retention, and operational controls outside this package.

Signing and verification callbacks must be supplied by the deployment. Their credential service and algorithm determine authentication, authorization, cryptographic strength, identity assurance, and non-repudiation properties. Passwords, private keys, tokens, and reusable secrets must not be placed in package objects.

An internally consistent earlier object is indistinguishable from the record as it existed at that time. Deployments that must detect whole-object rollback or removal of the current tail event need to retain verified audit head hashes in a validated external append-only store and compare them when records are retrieved.

A safe_harbor_candidate report is a conservative configured-field result, not a legal determination. Pseudonymized data remain personal data when separately held information permits re-identification. Structured header helpers do not rewrite binary files or inspect DICOM pixels. Data-subject erasure changes only the returned in-memory record collection.

Lifecycle and risk templates contain neutral project-authored headings and blank schemas, not licensed standard content. Risk decisions always come from a caller-supplied matrix and rationale. Conformance reports record PhysioExperiment project-policy checks, NOT_EVALUATED evidence, and relative paths; they are engineering-readiness records rather than conformity conclusions.

References

HHS OCR, Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the HIPAA Privacy Rule, https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/.

Regulation (EU) 2016/679, https://eur-lex.europa.eu/eli/reg/2016/679/oj.

DICOM PS3.15, Security and System Management Profiles, https://dicom.nema.org/medical/dicom/current/output/html/part15.html.

IEC 62304:2006+A1:2015, public catalog metadata, https://webstore.iec.ch/en/publication/22794.

ISO 14971:2019, public catalog metadata, https://www.iso.org/standard/72704.html.

See also

Useful links:

• https://github.com/x-biosignal/PhysioCompliance

• https://x-biosignal.r-universe.dev/PhysioCompliance

• https://x-biosignal.github.io/PhysioCompliance/

• Report bugs at https://github.com/x-biosignal/PhysioCompliance/issues

Author

Maintainer: Yusuke Matsui mail.to.matsui@gmail.com