The Health Insurance Portability and Accountability Act of 1996, also known as HIPAA, was originally created to give medical patients greater control and access over their health information.

The rules and guidelines enclosed within this and subsequent legislation changed how HIPAA-covered entities like doctors, clinics, insurance companies, and others — along with their business associates — were allowed to handle patient data.

One of the main points of HIPAA was to set standards for how protected health information (PHI) is handled when transferred electronically.

In this article, we’ll discuss the rules around electronic information transfer and how e-signatures can play a role in HIPAA compliance for healthcare providers and other covered entities.

What information does HIPAA cover?

First and foremost, the HIPAA regulation has a well-defined scope of action when it comes to the protection of customer data.

  • Information about an individual’s past, present, or future physical or mental health.
  • Information related to healthcare services provided to an individual, including payment and insurance information.
  • Personal identifying information that is collected, used, or disclosed during healthcare operations (for example, name, address, or social security number).

Also, keep in mind that HIPAA applies to all forms of PHI, whether electronic, written, or oral, and covers a wide range of healthcare organizations and professionals, including doctors, hospitals, health plans, pharmacies, and other healthcare providers.

When does HIPAA require the use of electronic signatures?

Digital signatures and signed documents have a strange place within HIPAA rules because HIPAA has no exact guidelines for how they should be captured while maintaining legal compliance.

Originally, electronic signatures were covered under the HIPAA Security Rule (1998), but all passages governing e-signatures were removed before the bill was passed in 2003.

The website for the Department of Health and Human Services (HHS) currently states the following regarding the electronic signatures and HIPAA’s privacy rule:

“Yes, assuming that the electronic contract satisfies the applicable requirements of State contract law. The Privacy Rule generally allows for electronic documents, including business associate contracts, to qualify as written documents for purposes of meeting the Rule’s requirements.”

HHS continues:

“However, currently, no standards exist under HIPAA for electronic signatures. In the absence of specific standards, covered entities must ensure any electronic signature used will result in a legally binding contract under applicable State or other law.”

In other words, as long as state law is satisfied, the use of e-signatures or an e-signature solution to sign documents maintains the integrity of PHI and doesn’t violate HIPAA rules.

Can I use electronic signatures to stay HIPAA compliant?

Healthcare industry professionals and healthcare organizations can use electronic signatures as a way to validate forms and protect themselves from potential HIPAA violations.

To do this, covered entities need to follow guidelines established by the Federal Electronic Signatures in Global and National Commerce Act (ESIGN Act) and the Uniform Electronic Transactions Act (UETA) in order to create acceptable electronic signatures.

These mandates allow for user authentication in a way that reduces tampering and maintains message integrity so that electronic signatures are considered authentic and legally binding.

How to use electronic signatures with your HIPAA documents

Now that you know more about HIPAA rules, here are the steps to follow with your electronic signature software for your documents.

  1. First, select an e-signature provider that complies with HIPAA regulations and provides the necessary security features to ensure the confidentiality and integrity of PHI.
  2. Next, choose the type of HIPAA document you want to send to your customers.
  3. Include a Business Associate Agreement (BAA) in your document to stay HIPAA compliant.
  4. Lastly, make sure your documents meet HIPAA standards by reviewing them regularly.

How can e-signature help healthcare providers manage HIPAA compliance?

Electronic signatures help healthcare providers manage HIPAA compliance as they simplify obtaining consent and authorization from patients while ensuring that all necessary data are securely stored and tracked.

By leveraging e-signatures in compliance with HIPAA, healthcare providers can improve patient care and minimize the risk of costly violations.

Is PandaDoc HIPAA compliant?

PandaDoc is a HIPAA compliant eSignature tool that offers the features and safeguards to protect electronic patient health information.

This includes secure document storage, access control, and audit trails — all essential aspects of HIPAA compliance.

What are the essential components your electronic signature must have under HIPAA?

Here’s a quick look at the essential items you need to cover when working with HIPAA electronic signatures:

Compliance

As mentioned above, HIPAA offers no additional guidance for electronic signatures in healthcare beyond what satisfies state and federal law.

As long as those requirements are met, any electronic signature that you use would be considered valid under HIPAA.

You’ll also need to ensure that the patient receives a copy of the document once the signing is complete.

Authorization

One of the biggest challenges when using electronic formats to send HIPAA-compliant documents comes down to authorization.

When sending electronic documents, you need to ensure that all disclosures are made following the HIPAA Privacy Rule and the HIPAA Security Rule.

This means that you’ll need to send your documents to a patient in a way that is validated and secure to avoid any breach of privacy.

You also need to make sure that you’re sending documents to the correct individual.

There are multiple methods that you can use for this, including two-step authentication, security questions, and phone validation.

Document integrity

When sending documents electronically, you’ll need to make sure that the documents can’t be tampered with after the form is filled out and signed.

This is part of the HIPAA Security Rule.

You could do this by locking the document, adding a password, or storing it in such a way that the document is secure and out of reach from everyone except authorized users.

Non-repudiation

Audit trails are essential for non-repudiation.

The risk with electronic signatures is that the signer can always deny ever signing the actual document.

An audit trail makes that far more difficult by including a timestamp for when the document was signed.

With PandaDoc, we go even further than normal standards with this by providing document insights to let you see real-time activity on your document.

You’ll know when it was opened, viewed, and signed so that you can stay on top of the process from start to finish.

Document control

Lastly, covered entities need to ensure that they have control of all necessary documents to prove the authenticity of their signed documents and the accompanying electronic signature.

In many cases, this comes down to digital certificates that can certify the authenticity of the document or downloading records to store them on file.

You’ll also need a way to effectively find the files that you need.

This is critical in the event of an audit.

How do electronic signatures benefit my HIPAA documents?

Allowing signers to fill out HIPAA-related documents can be a major boost to your administrative processing.

Because files can be sent and stored electronically, it’s now possible for many common HIPAA forms to be completed digitally, even by signers outside of the office.

From an administrative standpoint, this could allow front desk administrators to more effectively manage long waits and queue times.

In busy medical complexes like hospitals or clinics, filling out forms electronically could make for easier filing and greater legibility on the forms themselves.

Electronic signatures play an important role here because they can be used to prove that patients received all information relevant to them, including important disclosures like a company privacy policy or HIPAA compliance guidelines.

Under HIPAA, patients must be informed of their right to privacy and their ability to control their medical records.

They must also sign release forms allowing healthcare providers to transmit their data.

Electronic signatures can help with all of that by requesting that patients acknowledge that they have received this information and that they agree with organizational policies regarding data.

Manage you HIPAA signature forms with PandaDoc

PandaDoc can help covered entities in a few different ways.

Most importantly, PandaDoc provides a safe and secure environment where HIPAA documents can be signed and sent.

Our electronic signature tool makes acquiring digital signatures simple and easy while the document builder comes with a variety of tools to provide additional clarity and visibility throughout the signing process.

In addition to simple e-signatures, covered entities can use PandaDoc fields to add dates, initial boxes, checkboxes, and more to ensure that patients acknowledge specific parts of the required agreements and disclosures.

Contact our sales representatives now and sign up to start your PandaDoc demo.

Disclaimer

Parties other than PandaDoc may provide products, services, recommendations, or views on PandaDoc’s site (“Third Party Materials”). PandaDoc is not responsible for examining or evaluating such Third Party Materials, and does not provide any warranties relating to the Third Party Materials. Links to such Third Party Materials are for your convenience and does not constitute an endorsement of such Third Party Materials.

Originally published July 27, 2020, updated May 8, 2023