Securing Informed Consent

Informed consent is a means of giving permission from the patient to the practitioner for treatment to be provided. Consent forms ensure that all necessary information has been communicated to the patient who has had the opportunity to ask questions and fully understand the treatment being provided.

Consent via the use of iPads or signature pads to obtain an electronic signature is a popular method of obtaining informed consent using an electronic health record (EHR) instead of paper forms, yet questions may arise regarding the security and legality of such signatures.

In June 2000, the Electronic Signatures in Global and National Commerce Act (E-Sign Act) was signed into law, which legally validated the use of electronic records and signatures primarily for transactions regarding interstate or foreign commerce.¹ The E-Sign Act allows the use of electronic records to satisfy any statute, regulation, or rule of law requiring that such information be provided in writing, if the consumer has affirmatively consented to such use and has not withdrawn such consent.

In the United States, electronic signatures for consent must comply with 21 CFR 11(c), a federal regulation which requires an electronic signature to be unique to one individual, and organizations must verify the identity of the individual per the following stipulations:²

• Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
• Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
• Individuals using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.
• The certification shall be signed with a traditional handwritten signature and submitted in electronic or paper form.
• Individuals using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature.

Electronic consent can be obtained in-person or remotely, and eliminates the need for paper forms. Consent can be obtained electronically prior to the office visit if such forms are incorporated into the practice’s EHR system, allowing for streamlining the check-in process. Additionally, electronic signatures can be more secure than paper signatures as they are less susceptible to forgery.

Dental offices and organizations are realizing that electronic consents and signatures allow for greater efficiency, reduced costs, and improved patient experiences while being legally binding.

References

1. National Credit Union Administration. Overview. Available at: ncua.gov/regulation-supervision/manuals-guides/federal-consumer-financial-protection-guide. Accessed June 28, 2023.
2. National Archives. Code of Federal Regulations. Available at: ecfr.gov/​current/​title-21/​chapter-I/​subchapter-A/​part-11/​subpart-C#p-11.100(c)(1). Accessed June 28, 2023.

From Dimensions of Dental Hygiene. July/August 2023; 21(7):24.