Computer Technology

There’s an electronic signature in your future

At this time there are no universally accepted rules regarding the use or required characteristics of electronic signatures in healthcare settings. The Department of Health and Human Services is required by the Health Insurance Portability and Accountability Act (HIPAA) to develop standards for electronic signatures, but has retracted its initial proposal. There is no federal rule regarding the use of electronic signatures for nursing home care except for a memo dated January 13, 2005, that references the electronic signature rule for hospitals. The memo permits the use of electronic signatures for MDS forms even if the facility does not maintain a completely electronic record.

There are other potential uses for electronic signatures on the horizon. For example, healthcare information can be viewed as operational data that need protection, as would documents that will be used outside the institution such as claims, attachments, orders to vendors (such as laboratory and pharmacy), and other business uses. In addition, some internal documents need authentication by nonemployees, such as residents and family members. Physicians will also need to be able to authenticate notes and orders (although they would resist having a different process for the nursing facility than they use in the rest of their practice).

Implementing Electronic Signatures
Noncompliant implementation of the electronic signature can be disastrous for a provider. For instance, if documents can be changed after signing and still carry the signature, clinicians could be held accountable for statements they didn’t make, with possible fraud, malpractice, or false claims consequences. If the signature can be applied without the explicit permission of the individual, the individual could deny the document’s validity.

An example: Magee-Womens Hospital of University of Pittsburgh Medical Center is seeking to test all women who had pap smears at the facility between 1995 and 2001 because of a lawsuit by hospital pathologists who claim that they never reviewed the results to which their electronic signatures had been affixed. There are liability issues since the records cannot be validated as having been read by a pathologist. What might the consequences be if it can be proved that a patient suffered poor consequences of a health condition as the result of a poorly designed computer system?

We propose that the proper test of compliance is to assume that a record will be used in a court proceeding and will be subject to analysis by sophisticated forensic data experts who will have full access to the system generating the records. This is an excellent reason why clients should receive assurances that the facility’s electronic signature implementation meets the applicable known standards, not just marketing hype.

Implementation of the Electronic Signature
There are several rules for compliance: Electronic signatures must be applied to a document at the specific direction of the signer. The signer should have the opportunity to review his entries prior to signing, and the entry must be complete before signing. Then the document must not be able to be changed without the signature becoming invalid. A simple indication that a person “signed” a document is not sufficient. The system of record storage must be designed to ensure the identity of the signer, the intention of the signer to sign the document, the inability of the signer to deny signing the document, and that the document is exactly the document the signer signed.

Before an electronic signature is applied, the responsible clinician must have the opportunity to review the document he or she will be signing. Once an entry has been signed, the system must not allow the initial signed entry to be changed. Correction must be by way of an addendum, with an indicator that the original data have been corrected. Passwords, certificates, or other means of identifying individuals must be kept secure.

Data contained in an operational clinical database could be maintained in an intermediate state with the date/time of creation and the identity of the recorder. Data in this format would be editable and would not be considered a signed document. Its status could change to “signed” upon review by the signer and evidence of explicit intention to sign the document, preferably through use of the signer’s private key.

Clinical entries would thus have to have several levels of finality: draft, final, signed, co-signed, corrected (with an indicator of this), and deleted.

These levels will all have to be managed and the process made defensible to forensic data experts.

Emergency procedures to recover data when the individual who signed the data is not available should be developed. People do forget, lose tokens, leave the institution, or become unavailable to supply information that would ordinarily be needed to complete transactions.

Check Your Vendor
When a vendor proposes purchase of an electronic record, facilities must be given assurances that the most stringent requirements for document authentication have been met (see table). Also, facilities must ensure that the technology to be implemented is capable of evolving as the standards evolve. Contracts with vendors must be reviewed by competent legal counsel before signing to ensure protection of the residents, staff, and facility. Solutions that appear to meet standards on the surface may be very costly if the standards are not actually implemented. And don’t forget that states might have additional requirements that must also be met. Until a unified standard is in place and a valid certification process is available, proceed in this direction with caution.