There's an electronic signature in your future.

One key technology that the Centers for Medicare & Medicaid Services (CMS) needs before moving toward an electronic-record environment is the electronic signature, allowing providers to sign off on healthcare records electronically. Although there are no current mandates for this to happen in long-term care, you will inevitably hear about this technology and probably need to give it some informed thought in the near future. So, what are the implications of the electronic signature, and how will you know one the next time a vendor says he has one?

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.

David M. Oatway, RN, a long-term care IT consultant based in Key West, Florida, was the Department of Defense Project Officer for the initial clinical requirements phase of the Composite Health Care system (CHCS-I). He worked with HCFA/CMS on the Prospective Payment System for SNFs and contributed to the development of MDS 2.0. He developed one of the first clinical/MDS systems (CHAMP). He is the Chair of the Healthcare Information and Management Systems Society (HIMSS) Long Term Care and Post Acute Special Interest Group and a member of the American Health Information Management Association (AHIMA) and the Health Level Seven (HL7) organization. He was the vice-chair for the American Association of Nurse Assessment Coordinators. To send your comments to the author and editors, e-mail [e-mail]. To order reprints in quantities of 100 or more, call [phone].

NOTE: This document is a summary and analysis of the standards, rules, and practices in effect as of September 2005. This document is not intended to be and cannot be relied on as legal advice.

BY DAVID M. OATWAY, RN

RELATED ARTICLE: The Electronic Signature and the MDS

The electronic signature as applied to the MDS is a special case for nursing facilities that has clinical, regulatory, and financial issues. The MDS must be kept in a draft format until the responsible clinicians determine that it is complete. Since different clinicians can sign different sections, and in some cases more than one clinician can sign the same section, multiple signatures are essential. In addition, the RN that signs the Attestation cannot sign that until all sections are signed as complete. Once signed by the RN, the part of the document that was signed cannot be changed without invalidating that signature. This is important because additional parts of the MDS can have completion dates and signatures after the initial document is signed. For example, the RAPs and care-planning decisions can be in draft form while the data sections must be signed within the regulatory time frames. With current technology, changes to these sections after signing would require all affected sections to be re-signed.

--David M. Oatway, RN

Table. Mandatory/optional properties of the electronic signature

The mandatory properties for electronic signature are:

1. Nonrepudiation    The signed document cannot be denied to have been
                     signed by the signer.
2. Integrity         The document viewed is exactly the document signed
                     by the signer. No changes can be made without
                     invalidating the signature.
3. Secure user       The person signing is really that person.
   authentication

Seven optional properties are also specified:

1. Multiple          Required in many situations in which multiple
   signatures        clinicians participated in the creation of the
                     document. It is needed for MDS because of sections
                     signatures and signatures of the RNAC and Care
                     Planning coordinator.
2. Signature         Attributes maintained by the system: document
   attributes        creation date/time; document type; event date/time
                     (system- or user-assigned); document modification
                     and access time; location of origin; data types;
                     data format; originating organization; patient
                     identifier; document identifier.
3. Counter           It must be possible to determine the order of
   signatures        application of signatures.
4. Transportability  The signed document can be transported over
                     insecure networks while retaining its integrity,
                     including of content, signatures, signature
                     attributes, and document attributes.
5. Interoperability  The signed document can be processed by the
                     recipient.
6. Independent       It shall be possible to verify the signature
   verifiability     without the cooperation of the signer.
7. Continuity of     The public verification of a signature shall not
   signature         compromise the ability of the signed to apply an
                     additional secure signature at a later date.

--David M. Oatway, RN