By Morris W. Stemp, CPA, MBA, CPHIMS, October 01, 2014
In dermatology, informed consent is a component of a surgical procedure; current case law has established that failure to obtain informed consent makes a physician liable for negligence or battery, and may constitute medical malpractice.
Before EHR, consent was sometimes a verbal process and it was possible to misplace consent forms. Now that most doctors are using EHR, paper consent forms are often being scanned into the EHR. But the process of printing a consent form, filling in the name of the procedure, having the patient manually sign it, scanning the signed form, and then either filing or shredding the signed document, is very time consuming. It is possible, though, to save time and effort by documenting informed consent electronically.
Purpose of informed consent
Informed consent has two purposes.
- Educate the patient regarding the proposed medical treatment. Patients often forget what is spoken to them, so the most effective way to provide this education is to also provide something in writing in simple, easy-to-understand language, using non-medical terminology
- Protect the doctor from liability. Almost 6 percent of malpractice claims arise from problems with informed consent, according to the Physician Insurers Association of America (PIAA).
Regardless of how the education is provided, there can be no protection from liability without having proper documentation of the consent taking place before treatment. The goal of this article is to describe the available technology to support the full informed consent process in an automated, efficient manner. Informed consent is a process, not just a signature.
Informed consent process
The informed consent process includes:
- Delivery of the education along with confirmation that the education was understood
- Presentation of the informed consent (or possibly refusal) form
- Patient acknowledgment via signature
- Documentation of consent in medical record
Technology is available to support each of these steps in the informed consent process with products supporting all or part of the processes. The most widely available technology addresses the process of obtaining, tracking, and verifying patient signatures so this review will focus on this step of the process first. Then a review of technologies available for the other steps will be presented.
Patient acknowledgement via electronic signature
An electronic signature can be an image of a handwritten signature, a voiceprint, a signing with the click of a mouse or even signing by using a finger or mouse to trace a signature onto a document. These types of signatures present a number of legal verification problems including:
- There is no proof as to when the document was signed (before or after procedure)
- The image of the signature could have been copied from one document to another
- The document can be manipulated after signing
A more secure type of electronic signature is a digital signature. This type of signature links the document to the signer’s identity so that the signer’s information is permanently embedded into the document along with the date and time of the signature. A facsimile of the signature and evidence of the signature’s validity may be viewed by opening the PDF document. Any alteration of the document after being digitally signed will cause the digital signature to become invalid. A digital signature is legally enforceable.
If one of the purposes of informed consent is to provide legal protection for the doctor, then I believe doctors should focus on solutions that provide the highest level of signature verification to withstand rigorous legal scrutiny.[pagebreak]
Signature technology solutions
There are several vendors that offer HIPAA-compliant solutions for obtaining a digital signature. Cloud-based solutions enable the consent document to be sent via email and signed online via a Web browser. Others only enable the signing onsite via an electronic signature pad. Some also allow for having several data entry fields with buttons, check boxes, fill-in responses, and more than one signature. A few even allow for data collected on the consent form to be integrated into specific fields of an EHR medical record.
DocuSign, EchoSign, RightSignature, and SIGNiX are non-health care specific systems which make the e-signing process secure and simple. In a medical practice environment, the office sends a patient an encrypted email with a link to the informed consent form. The patient views the forms online, fills in the required fields, initials and signs where requested, and then submits the completed form. A copy of the form is then emailed to the patient and the doctor, and the practice can import the document into the EHR. These systems also maintain a cloud-hosted dashboard of all documents ever signed for the practice.
These systems vary in terms of features and prices. Pricing varies based on the number of users and number of documents. Expect to budget about $20 per user per month for unlimited documents. For a small, one-location dermatology practice, generally only one user will be needed.
If the patient is in the office, sending an email to obtain a signature online may not be the best process for obtaining consent. The SIGNiX solution offers a new capability of in-person signing. The office staff specifies that the document will be signed “in person” and the form may then be viewed and signed on an iPad or Windows 8 touch screen.
In-office signature pad solutions
Solutions which allow you to collect the patient’s signature on a digital signature pad are ideal for obtaining signatures in the office. In the basic signature pad solution, a practice purchases a low-cost signature capture pad with stylus ($100 to $250 on Amazon) and downloads the software required to create signature fields on a PDF or Word document. The patient views the consent form on paper or on a computer monitor, and then consents by signing the signature pad with a stylus. When the patient signs, the signature is digitally embedded in the document. The office staff then saves the PDF document, naming it to identify it as that patient’s informed consent form. The form may then be imported into the patient’s EHR medical record.
More expensive solutions offer the option of a larger display which allows the patient to simultaneously view and sign the form. Some vendors just sell the signature capture software by itself to enable the use of iPads and tablets as signature capture devices.
There are several vendors offering signature pad solutions including Topaz, Wacom, ePadLink, and Signotec. One innovative vendor offers a full screen capture device called the Zignature Pad (approx. $800) which allows a form to be viewed and signed on a portable tablet-style device.
Phreesia is a vendor that provides a free wireless tablet that enables patients to enter and update demographics and insurance information during check-in, sign HIPAA forms, and pay co-pays using a built-in credit card swipe. The system can also present any type of educational content or form to a patient, including an informed consent form, to view and digitally sign. Phreesia is integrated with a number of EHR systems and can have the signed forms attached to the patient record.[pagebreak]
There are many systems that provide medical education to patients. In fact, providing educational materials to patients regarding their specific medical conditions is required by Meaningful Use. What is unique about a product called iMedConsent PE is that it generates this educational content in the format of an informed consent form including all the elements noted above (procedure description, risks, benefits, etc.). The product also facilitates digital signature capture on the generated form and integrates with various EHR systems. Dialog Medical maintains a library of dermatology-specific educational material and consents in English and Spanish. iMedConsent PE costs $695 for a single doctor license plus $295 for each subsequent year renewal.
While iMedConsent is a content creation tool, Systemedicus EduConsent is a content delivery system which requires that the practice already has the educational content to present with the consent forms. An iPad is used to present the medical practice’s consent documents which can include not only text, but also photos, illustrations, graphics, charts, and videos. Different versions of text can be accessed by the patient, based on the patient’s level of education, age, and preferred language. The size of the font can be adjusted for increased legibility or a text-to-speech mode can be used. Basically, the system has features to deliver the consent education in as easy-to- read and comprehensible a manner as possible.
The most important feature of the system is called “comprehension checkpoints.” This feature tests a patient’s level of understanding via a series of questions. Correct answers are recorded by the system and the patient is allowed to read on to the next section. Incorrect answers redirect the patient to the relevant information and the patient is given another chance to answer the question. The entire process is time and date stamped and recorded on video. Page turns are timed, and educational videos cannot be fast forwarded or skipped.
After the patient completes the education process, the physician is also recorded on the video, asking the patient if he or she has any questions about the procedure thereby documenting the entire doctor-patient interaction. Thus, an indisputable record is produced as evidence that a full informed consent process was concluded. The patient signs the consent with a digital signature and a PDF of the consent is emailed to the patient and the physician. The medical practice then saves the signed consent in the EHR. EduConsent is licensed on an annual basis and pricing depends on how much customization is required.[pagebreak]
Other areas where consent is needed
In addition to the requirement for informed consent before a medical procedure, consent forms are used for other purposes in a medical practice.
Consent for use of the patient portal
Stage 2 of Meaningful Use requires that at least 5 percent of patients view, download, and transmit their health information and send a secure electronic message to their provider. To comply with this patient engagement requirement of Meaningful Use, physicians might offer their patients the opportunity to access their health records through a patient portal. This is typically a module provided by the EHR system. It permits the patient to view clinical treatment information, request an appointment, and to securely communicate with the physician or the medical office staff.
According to HealthIT.gov, it is not required to have the patient sign a consent to use the portal. However, it is advisable to have the patient read the policies and procedures for use of the portal and to sign a document, often called informed consent, acknowledging the risks of using the portal and agreeing to its appropriate use.
Consent for health information exchange
Meaningful Use Stage 2 requires that doctors electronically share summary of care information when referring a patient to another provider. Generally, this electronic sharing will be via the use of a health information exchange or HIE. Patients are asked to sign consent to allow their health care provider to view their health information that is shared on the HIE, a topic I covered last year in Dermatology World.
Based on state laws and the requirements of each HIE, consent may be requested before a physician can share or view a patient’s information via an HIE.
HHS launched a site in September 2013 known as Meaningful Consent, which “addresses the laws, policies, and issues related to the electronic exchange of health information.” The resources educate patients regarding whether to share their medical information via an HIE.
Informed consent is a process requiring education, a signature, and documentation. This benefits both the provider, by limiting liability, and the patient, by setting expectations and thereby improving satisfaction. Automating the consent process can reduce the risk of litigation in malpractice claims which arise from the discrepancy between the patient’s expectations and the outcome of the treatment. Technology is available to enable medical practices to implement a consent process which provides a high level of education insuring that patients are indeed informed, and creates indisputable evidence of consent all in an automated and efficient manner.
This article is not intended to provide legal advice or to define a procedure for obtaining consent.
- "Consent issues” was the second-most-common legal matter reported in claims made against dermatologists over the last 25 years.
- Solutions that allow you to collect the patient’s signature on a digital signature pad or touch screen are ideal for obtaining patient informed consent.
- Beyond obtaining a signature, technology is also available to support the education process.
- Consent involves education, not just signing a form.