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Signing Electronic Medical Records
| Author: By William Zelman, DO FACOOG, and Michael Zelman, Esq. |
| Article Date: 11/1/2007 |
Compared to physicians who cling to paper charts, practitioners who use an
electronic medical record system (EMR) enjoy tremendous savings of time and expense
in the day to day entry and retrieval of patient information. But what happens when a
problem occurs and the patient record becomes evidence in a legal or quasi - legal
proceeding? Will an EMR be afforded the same weight and credibility as a paper chart?
Should an EMR be contemporaneously printed and signed by the physician or staff
member? These are important questions for anyone who uses, or is thinking of using, an
EMR program. We will explore the problem, and offer some ideas.
LetÕs look at paper charts first. An entry is made by staff or physician, but usually signed (or initialed) by the physician. In the instance of a staff members entry, what exactly does a physician signature mean? That the entry is approved and adopted? That the entry is believed true and the physician is relying upon it? That the physician has merely read the entry? Perhaps the physician intended none of the above, as it is simply office procedure for a physician to sign everything that staff places on the physicianÕs desk.
Even the instance of a physician signing his or her own entry is not so simple. Is the physician declaring that the entry, which contains information gathered by staff, is accurate? Maybe the physician intended only to convey that he or she made the entry, and nothing more.
By now it should be obvious that a signature on a medical record is not conclusive evidence by itself. In any adversarial setting a practitioner should expect that it will be necessary to explain the precise meaning of entry signatures. But signatures do have one unambiguous aspect. Each signature is unique, and thus a physician signed entry means the physician, and no one else, signed the entry. Moreover, if it can be shown that the entry was signed contemporaneous (or reasonably so) with the entryÕs creation, the entry will likely be found genuine and will likely withstand any claim of subsequent fabrication. In the highly contentious world of medical litigation, avoiding problems of this sort should be of paramount importance to any practitioner.
But we are concerned with EMR software, and the whole purpose of having a computer system is to simplify and enhance record keeping. Thus although it could be done, an EMR program which permits a physician to physically sign each entry by means of a touch pad device-much like retailers use for credit card purchases-would not be a step forward. Moreover, the result would still be subject to alteration (by cutting and pasting) and thus not a solution. So at this point you may think that the answer is to print out every entry for signing and dating. Indeed, this is one solution, but a time consuming one. There should be a better way-and maybe there is. LetÕs consider the problem further.
First, it is significant that EMR printouts - whenever they are generated - are generally admissible in legal proceedings. The courts long ago accepted computer records, and EMRÕs are just another variant. But there are a few cautions which could affect admissibility or even liability. Some jurisdictions may have laws or regulations which require physical signatures or other information. In Florida, for example, the Department of Health, Board of Medicine, requires dating, but not signing, of office records. Then there are the payors, who may have their own rules or contracts which require physical signatures or other information. Additionally, there are accreditation organizations and other sanctioning authorities that may have requirements. If any of these situations are present the practitioner must follow these cautions.
Second, there are efforts underway to standardize ÒelectronicÓ or ÒdigitalÓ signatures. Congress, the states, the American Bar Association, and private industry are all looking into and working on the issue. In fact, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), directs the standardization and acceptance of electronic signatures. HIPAAÕs mandate is still a few years off, so it is not clear what impact it will ultimately have. Moreover, the subject of electronic and digital signatures is generally concerned with transmission of data to legally bind the sender - to provide strong and substantial evidence that will make it difficult for the signer to claim that the electronic representation is not valid. This is the logical inverse of our problem - to provide strong and substantial evidence to make it difficult for another to claim that the signerÕs electronic representation is not valid.
Third, there is electronic signature software that purports to ÒsignÓ computer files in a manner that cannot be changed. However, since there are as yet no standards for electronic signatures for EMRs, using one of these programs is itself no guarantee that your subsequent printouts will survive a claim of tampering or fabrication.
For now, a good EMR program is its own solution. EMR programs permit staff and physicians to make entries, and every good program should have a password log on requirement which irrefutably identifies the author of every entry. Moreover, the program should have a specific system for permanently saving the entry in a manner which forbids subsequent alteration. Once these systems are in place the basic attributes for an EMR equivalent ÒsignatureÓ are established.
For example, PowerMed CorporationÕs EMR program incorporates these systems in a logical manner. Every user must log on with a password, which then identifies every entry made by the user. Rather than making the entry indelible immediately, PowerMed permits editing and deletion until midnight, but then the entry is permanently established and dated. This late night Òlock outÓ feature is a reasonable compromise between the need for legitimate editing and the need for a permanent unalterable entry. When an addendum to an entry is required, PowerMed dates the addendum with its own creation date, and leaves the entry untouched. The password and lock out features of PowerMed should preclude allegations of backdating or other nefarious tampering. However, for those inclined, PowerMed prints all daily entries on detachable adhesive strips, which can then be signed and added to individual patient paper charts.
Thus an EMR program with password and lock out features automatically places a virtual electronic signature on every entry. This remains true regardless of when the chart is actually printed, because the entries could not have been created, altered, or deleted after the lock out deadline. However, at least until there is formal legal recognition of electronic signatures, some EMR users may prefer the extra security of daily printing and signing of entries. If you do, just remember to occasionally ask yourself what exactly that signature means.
LetÕs look at paper charts first. An entry is made by staff or physician, but usually signed (or initialed) by the physician. In the instance of a staff members entry, what exactly does a physician signature mean? That the entry is approved and adopted? That the entry is believed true and the physician is relying upon it? That the physician has merely read the entry? Perhaps the physician intended none of the above, as it is simply office procedure for a physician to sign everything that staff places on the physicianÕs desk.
Even the instance of a physician signing his or her own entry is not so simple. Is the physician declaring that the entry, which contains information gathered by staff, is accurate? Maybe the physician intended only to convey that he or she made the entry, and nothing more.
By now it should be obvious that a signature on a medical record is not conclusive evidence by itself. In any adversarial setting a practitioner should expect that it will be necessary to explain the precise meaning of entry signatures. But signatures do have one unambiguous aspect. Each signature is unique, and thus a physician signed entry means the physician, and no one else, signed the entry. Moreover, if it can be shown that the entry was signed contemporaneous (or reasonably so) with the entryÕs creation, the entry will likely be found genuine and will likely withstand any claim of subsequent fabrication. In the highly contentious world of medical litigation, avoiding problems of this sort should be of paramount importance to any practitioner.
But we are concerned with EMR software, and the whole purpose of having a computer system is to simplify and enhance record keeping. Thus although it could be done, an EMR program which permits a physician to physically sign each entry by means of a touch pad device-much like retailers use for credit card purchases-would not be a step forward. Moreover, the result would still be subject to alteration (by cutting and pasting) and thus not a solution. So at this point you may think that the answer is to print out every entry for signing and dating. Indeed, this is one solution, but a time consuming one. There should be a better way-and maybe there is. LetÕs consider the problem further.
First, it is significant that EMR printouts - whenever they are generated - are generally admissible in legal proceedings. The courts long ago accepted computer records, and EMRÕs are just another variant. But there are a few cautions which could affect admissibility or even liability. Some jurisdictions may have laws or regulations which require physical signatures or other information. In Florida, for example, the Department of Health, Board of Medicine, requires dating, but not signing, of office records. Then there are the payors, who may have their own rules or contracts which require physical signatures or other information. Additionally, there are accreditation organizations and other sanctioning authorities that may have requirements. If any of these situations are present the practitioner must follow these cautions.
Second, there are efforts underway to standardize ÒelectronicÓ or ÒdigitalÓ signatures. Congress, the states, the American Bar Association, and private industry are all looking into and working on the issue. In fact, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), directs the standardization and acceptance of electronic signatures. HIPAAÕs mandate is still a few years off, so it is not clear what impact it will ultimately have. Moreover, the subject of electronic and digital signatures is generally concerned with transmission of data to legally bind the sender - to provide strong and substantial evidence that will make it difficult for the signer to claim that the electronic representation is not valid. This is the logical inverse of our problem - to provide strong and substantial evidence to make it difficult for another to claim that the signerÕs electronic representation is not valid.
Third, there is electronic signature software that purports to ÒsignÓ computer files in a manner that cannot be changed. However, since there are as yet no standards for electronic signatures for EMRs, using one of these programs is itself no guarantee that your subsequent printouts will survive a claim of tampering or fabrication.
For now, a good EMR program is its own solution. EMR programs permit staff and physicians to make entries, and every good program should have a password log on requirement which irrefutably identifies the author of every entry. Moreover, the program should have a specific system for permanently saving the entry in a manner which forbids subsequent alteration. Once these systems are in place the basic attributes for an EMR equivalent ÒsignatureÓ are established.
For example, PowerMed CorporationÕs EMR program incorporates these systems in a logical manner. Every user must log on with a password, which then identifies every entry made by the user. Rather than making the entry indelible immediately, PowerMed permits editing and deletion until midnight, but then the entry is permanently established and dated. This late night Òlock outÓ feature is a reasonable compromise between the need for legitimate editing and the need for a permanent unalterable entry. When an addendum to an entry is required, PowerMed dates the addendum with its own creation date, and leaves the entry untouched. The password and lock out features of PowerMed should preclude allegations of backdating or other nefarious tampering. However, for those inclined, PowerMed prints all daily entries on detachable adhesive strips, which can then be signed and added to individual patient paper charts.
Thus an EMR program with password and lock out features automatically places a virtual electronic signature on every entry. This remains true regardless of when the chart is actually printed, because the entries could not have been created, altered, or deleted after the lock out deadline. However, at least until there is formal legal recognition of electronic signatures, some EMR users may prefer the extra security of daily printing and signing of entries. If you do, just remember to occasionally ask yourself what exactly that signature means.