With the digitization of signing processes across various facets of life, it will come as no surprise that there’s been a significant uptick in interest and use of electronic signing for consent in fertility. Last week, I joined the CEO of REI protect, Dr. Steven Katz and other industry leaders for a virtual roundtable about what clinics want and need to know about eSignature technology. This blog is a compilation of the key questions asked by clinics across the country, along with the answers and guidance you need for a successful implementation.
Are electronic signatures valid?
Let’s start with the basics. The ESIGN Act (Electronic Signatures in Global and National Commerce) was passed at the federal level in 2000. This act solidified the legal landscape for use of electronic signatures, defined as “an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.”
Most importantly, the ESIGN act establishes that electronic records and signatures carry the same weight and legal effect as traditional paper documents and handwritten signatures. Additionally, documents or signatures cannot be denied legal effect or enforceability solely because they are in electronic form.
Can I use electronic signatures in a healthcare setting?
eSignature is being widely adopted in the health care space, including fertility. However, there are varying degrees of eSignature quality. You should be cognizant of the different features available when choosing a solution in order to best mitigate your risk as a practice. A few examples that, without exception, need to be built into your solution in order to align with the ESIGN Act and HIPAA guidelines:
- Consumer disclosure: The signer must actively consent to use an electronic format, with the ability to opt out.
- Retention of records: Documents must be retained and accessible in an unalterable format to people who are entitled to access it. This must be done in a secure and tamper-proof manner.
- Audit Logging: Record all important activities that occur on a document (i.e. who opened, viewed, signed – when, where and how)
- Signer Authentication: Understand the risk behind documents, and choose appropriate forms of authentication to verify signers (i.e. multi-factor authentication via SMS, or government ID verification)
- BAA: Having a BAA in place with your chosen vendor is a requirement for HIPAA compliance. However, this alone does not make you HIPAA compliant; You must also implement and adhere to appropriate policies, workflows, and technical controls.
Do I need to require use of a notary?
Notarization or witnessing is simply a form of signer authentication in order to mitigate risk. The fertility space is unique in its need for a stringent authentication process; however, notarization is NOT foolproof. There have been recent cases due to fraudulent behavior with a notary in which all parties (patient, notary, and medical practice) were brought to the courtroom.
eSignature allows for alternative forms of digital authentication to mitigate authentication risk. For example, you can combine SMS authentication or a digital ID verification process with an eSignature to demonstrate that you have a robust authentication process.
What other advantages does eSignature provide in terms of risk mitigation?
eSignature reduces risk in many other ways that paper documents are incapable of. By digitizing the entire signing process, you can feel confident that:
- Documents are complete: eSignature platforms have controls in place to ensure that each field is completed before moving to the next signer
- Documents are more accurate: Conditional logic built into electronic documents allows you to guide your patients through the signing process
- Documents are never misplaced or lost: It’s impossible to lose a digital copy using a well designed eSignature platform
Ultimately, you want to put a program in place that reduces your risk across the entire informed consent process. We see a wide array of adoption and risk tolerance with our customers. Most of the practices we work with opt to go completely digital, but some do keep the most sensitive forms for in person signature only (i.e. embryo disposition, thaw/transfer of frozen embryos, etc.).
Role of video consenting for IVF
Regardless of how you complete consent documents, simply having signatures on paper is not informed consent. We’ll save this topic for another post as there are many parallels between a video consent solution and an eSignature solution in terms of a consistent, comprehensive, secure, and thoroughly documented process.
Ready to learn more about EngagedMD’s eSign solution?