The healthcare industry is witnessing rapid changes, all introduced with the objective of improving the quality of care and ensuring positive outcomes for patients. The electronic medical record is one such innovative change, which saw mixed response on the part of physicians and healthcare providers. The system has a number of plus points, though there are certain roadblocks in the way of its successful implementation. In this changing scenario, significant changes are there as regards what information becomes evidence in litigation and how that information will be considered as evidence. Attorneys who are engaged in medical records review for personal injury and mass tort cases need to be aware of the important changes in this regard.
The Nature of PHI or Protected Health Information
- Under HIPAA, PHI (protected health information) is individually available health information that is transmitted via electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium.
- PHI is ESI or electronically stored information including:
- Data that is stored, processed, retrieved or transferred by primary and secondary electronic storage devices such as hard disk drives, diskettes, Flash drives, CD/DVD disk media, SIM cards, multimedia cards, smart cards, chip cards, integrated circuit cards, bar codes, punch cards, thumb drives, external hard disk drives, radiofrequency identification tags.
- Office backup/archival data on magnetic tape, disk media, bar code paper records, CD/DVD
- Cloud storage
- Data stored in the computer RAM
The ESI is transmitted between electronic storage device sources through the internet, radio, Wi-Fi, cable, broadband, satellite, cellular, barcode, dial-up telephone lines, connected external devices, extranets, and so on. The PHI or ESI stored or transmitted via any of these means of transmission are considered sources of discoverable information.
Metadata as Discoverable Evidence
Covered entities under HIPAA are required to use â€śaudit controlsâ€ť such as hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health informationâ€ť and to â€śimplement procedures to regularly review records of information system activity, such as audit logs, access reports and security tracking reports.â€ť The invisible, embedded â€śdata about dataâ€ť that meticulously tracks every entry into the computer is called metadata, which is the best legal evidence whenever there is some doubt regarding the information placed in a record, irrespective of whether it is in a letter, email, EMR or spreadsheet. This metadata is not part of the patientâ€™s formal medical record. However, it is a rich repository of vital information that may not be otherwise obtainable in discovery.
- The metadata generated by audit control systems reveals all deletions, alterations and suspicious entries.
- It provides the â€śwho, when, what and whereâ€ť for everything so that everything is transparent.
- It is used as evidence of physicians and other healthcare providersâ€™ conduct and credibility.
- In medical malpractice litigation, metadata is used as a tool to evaluate the quality and quantity of physiciansâ€™ clinical practices
Electronic evidence can be an important part of legal proceedings, deciding the course of a case. The Federal Rules of Civil Procedure and the Federal Rules of Evidence govern the acceptability of digital evidence in federal court. In state courts, state court rules of procedure and evidence decide the admissibility of digital evidence, and this may vary from one state to another. For any evidence to be acceptable in court, it must meet certain criteria, among which authenticity is an important factor. Metadata is validated on the basis of proof regarding how it was generated and why it is accurate.
In this age of electronic records, ESI or electronically stored information can run into thousands of pages making it challenging if not impossible for an attorneyâ€™s office to handle the medical record review. Professional medical review services would be the practical option, ensuring timely review of the medical records and collecting the vital medical evidence required for litigation purposes.