Questions about EHR Credence?
Electronic health records (EHRs) are real-time, patient-centered records. They make information available instantly, whenever and wherever it is needed. And they bring together in one place everything about a patient’s health.
One of the key features of an EHR is that it can be created, managed, and consulted by authorized providers and staff across more than one health care organization.
A single EHR can bring together information from current and past doctors, emergency facilities, school and workplace clinics, pharmacies, laboratories, and medical imaging facilities.
As more healthcare establishments change from paper to EHRs in the coming years, litigation involving EHRs will become common.
EHRs take the paper chart and shuffle it like a deck of cards.
And, what is seen on the computer screen is different than on the printed summary documents provided to attorneys who request medical records.
The resulting record is tedious, slow and difficult to navigate. Attorneys should expect a bigger workload.
Legitimacy of the EHR
One of the most basic apprehensions for EHR implementation was on legal concerns, particularly relating to the admissibility of medical records assembled electronically and their authentication.
Revisions to state laws as well as other legal and regulatory programs directing admissibility and authentication have diminished this worry in some measure.
Laws regarding technology usually will trail behind the actual technology. The laws of health information technology (HIT) are starting to catch up.
Foundations of Law
State law principally delivers the legal basis for health records, whether paper-based or electronic. (For instance, the legal directives for health records or medical documentation rooted in hospital and professional licensure laws.)
Laws with reference to general business records are also a source of law concerning whether health records are admissible in court.
Several of these laws passed before computers even existed, or at least before they became common.
Those laws do not address electronic records, leaving case law (judicial decisions) to resolve the legal issues.
The good news is that numerous states are bringing up-to-date their laws about electronic records, as well as for the release of information within a health information exchange (HIE) environment.
A couple of examples of newer state laws consist of:
• New Jersey Administration code 8:43G-15. 2 (b) (1) (1998) insists on the hospital developing a procedure to assure the confidentiality of each electronic signature and to prohibit the improper or unauthorized use of any computer-generated signature. The New Jersey Board of Medical Examiners and the Board of Physical Therapy oblige their licensees to create systems that are devised to protect the integrity, authenticity, and confidentiality of the patient records retained in electronic medical records.
• New York revised its hospital medical records rules in 1998. 10 NYCRR 405.10(c) necessitates hospitals to provide assurances regarding authenticity, security, and confidentiality. They must implement internal criteria for measures for the use of computerized medical records. This regulation clearly made electronic signatures and computer-generated signature codes acceptable as authentication when used according to the hospital policy. Similarly, the date, time, category of practitioner, mode of transmission, and point of origin must be in the medical record for every electronic or computer entry. New York also demands hospitals to guarantee that electronic communications and entries are accurate, providing two examples of acceptable ongoing verification processes:
– Protocols safeguarding that incomplete entries, reports, or documents are not recognized or implemented until reviewed, completed, and substantiated by the author
– A process implemented as part of the hospital’s quality assurance actions that afford for the sampling of records for review to confirm the accuracy and integrity of the system
Additional Bases Supportive to Electronic Signatures and Records
When state law has not been modernized or does not speak to EHRs, the clear trend is toward acceptance with appropriate controls. Correspondingly, other sources of direction can be useful. Case law typically provides presidence.
There is not a lot of case law relating to EHRs, which is a good sign that they are being accepted as an alternative of paper records.
An example of one case that supports electronic signature is Walgreen Co. v. Wisconsin Pharmacy Examining Board, No. 97-1513, 217 Wis.2d 290, 577 N.W.2d 387, 1998 W L 65551 at 4 (Wis. App. Feb. 19, 1998).
In this case, the Wisconsin State Court held that electronically conveyed prescriptions were comparable to prescriptions communicated verbally by telephone, which Wisconsin statute expressly allows filling without being signed by the physician.
In addition to state law and case law, the Medicare Conditions of Participation (CoP) deal with issues relating to the secure storage of records.
The joint Commission, in its healthcare organization accreditation program, holds establishments accountable for safeguarding that they have a mechanism in place to safeguard records and information against loss, destruction, tampering, and unauthorized access or use.
While the Health Insurance Portability and Accountability Act (HIPAA) does not overtly address the legality of protected health information (PHI) in electronic form, it does endorse the use of information systems and provides for the privacy and security of PHI and electronic media.
HIPAA called for recommendations on standardized data standards for patient medical record information that set the stage for many of the standards adopted now.
Still further explicitly, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) called for the implementation of standards to support e-prescribing (e-Rx), including acceptance of electronic prescriptions in all states.
MMA also provided for safe harbors and exceptions to the Stark law and Anti-Kickback statute that enable hospitals to provide certain e-RX and EHR arrangements (42 CFR 1001, 42 CFR 411). Regulations about the donation arrangement set forth the detailed provisions under which these arrangements can occur.
The American Recovery and Reinvestment Act (ARRA) of 2009 in its Health Information Technology for Economic and Clinical Health (HITECH) Act meaningfully advanced the concept that EHR was significant technology.
HITECH addresses some areas where the HIPAA Privacy Rule needs updating, clarification, and enhancements. The HITECHs criteria on EHR certification for the Medicare and Medicaid incentive program for meaningful use (MU) of EHR technology also includes plain security controls that strengthen the HIPAA security rule.
EHRs will be in litigation, but will they tell the story?
Clear, easy to read medical records can defend the medicine behind them.
But, traditional paper records are a thing of the past.
Today, EHRs are becoming commonplace in legal proceedings and showcased in trials, sometimes with millions of dollars on the line. Legal teams need to have a willingness to think outside of the box.
Legal nurse consultants analyze the voluminous information in the EHR and understand the effect that using electronic data collection, data entry, and clinical decision support tools can have on patient care.
These computer records may not always be so clear and readable. Who will you call upon to explain the EHR to your legal team? Can you decipher what the record says, and what it really means? If your records that cannot be satisfactorily presented to the court, you can lose the case before you start.
Call Krug Consulting today to review your cases involving EHRs.
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References:
42 CFR Part 1001. 2006 (August 8). Department of Health and Human Services, Office of Inspector General. Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Save Harbors for Certain Electronic Prescribing and Electronic Health Records Arrangements Under the Anti-Kickback Statute.
42 CFR Part 411. 2006 (August 8). Department of Health and Human Services, Centers for Medicare and Medicaid Services. Final Rule: Medicare Program: Physicians’ Referrals to Health Care Entities with Which They Have Financial Relationships, Exceptions for Certain Electronic Prescribing and Electronic Health Records Arrangements.