These rules and regulations mentioned under HIPAA and many other subsequent laws or acts changed how medical entities covered under HIPAA such as healthcare centres, clinics, doctors or insurance businesses, others covered under HIPAA including their business associates could handle critical patient data.
One of the crucial uses or emphases made by HIPAA was to define clear standards for how protected health information should be handled while being transferred electronically or digitally.
This write up will help you understand more about the rules and regulation of HIPAA that are guiding all the concerned electronic information transfer and how eSignature Healthcare Solutions can be looked at in this set up while many healthcare providers and other entities covered under HIPAA will be using them.
Let us understand the background behind the formulation of HIPAA rules and digital signatures:
As a matter of fact, HIPAA has no specific guidelines for the use of Digital signatures, electronically signed documents and how they should be captured without losing legal compliance.
The website for the Department of Health and Human Services (HHS) presently mentions::
However, presently, there are no specific standards under HIPAA for digital signatures. In the absence of any standards, HIPAA covered entities should make sure that any digital signature they are using will create a legally valid contract as per the laws of the land and all the applicable laws.
The Office for Civil Rights (OCR) states that as long as state laws are followed, the use of electronic signatures or use of Electronic Signature software to make signatures on the documents do not fail to keep the integrity of PHI intact and also do not violate HIPAA rules.
Here are the HIPAA requirements and regulations for the use of eSignature Solution for Healthcare Professionals:
The Healthcare sector is utilizing Electronic Signature software as it has proven to help healthcare businesses in making operational and administrative activities more efficient while they are being performed by healthcare businesses regularly.
However, there are still a few healthcare businesses in the market that are not aware of the HIPAA electronic signature requirements and hence, not confident enough to switch to electronic signature software.
Are digital signatures or electronic signatures the same as the signatures made by patients on physical documents? Do they comply with HIPAA regulations? Well, if the eSignature Solution for Government Agencies or healthcare business is using a specific mechanism to make sure that the security and legality of the data, agreement, document, record or file, and no threat is posed to the integrity of professional healthcare information, it is approvable for HIPAA covered organisations or professionals to use electronic signature software prove that the patient or the concerns signatory has carefully bread the document before signing it, and the signatory agrees with the content mentioned on the document.
Is there a mention of E-Signatures in HIPAA?
When the first draft of the 2003 Security Rule was prepared, mention was made concerning the use of electronic signatures under HIPAA.
But it was removed afterwards before the draft could become law. Afterwards, one guidance was released concerning BAA that is Business Associate Agreements and the sharing of digital health data.
It was published in the official health department of the U.S. saying, there do not exist any specific rules, standards or requirements under HIPAA for the use of electronic signatures.
As these standards do not exist, the HIPAA covered entities must make sure of one thing that the digital signature solution they are using to make digital signatures will form a law binding document as per the other laws of the land. (we have seen this above).
In fact, in the real world, there are hardly any occasions where signatures are not required for successful healthcare transactions, hence the problem of electronic signatures complying with HIPAA rules is irrelevant.
But, there are two cases where signatures are mandatory. One is while signing a business associate agreement and another one is while conducting patient authorizations.
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Many software businesses and cloud service providers are considered as business associates of HIPAA supported setups, as These software or services deal directly with patient health records.
In the same way, a business associate agreement must be acquired from these companies before they start offering their services. This must be duly signed and what can be the perfect, secured and faster way of signing such types of agreement than esignature healthcare solutions?
Patients must approve the use or disclosure of PHI that is not approved by the rules mentioned in the HIPAA Privacy Rule.
Patients can give this approval in writing during a personal visit or they can also share an electronic approval. Patients can utilize digital signatures in such cases to confirm that they have allowed the use of certain PHI.
Requirements for E-Signatures As Per HIPAA Rules:
As there is no mention of electronic signatures in HIPAA Rules, and the HHS has not banned the use, use of electronic signature software, the software can be used if it is in compliance with the laws of the land and in the case of the USA, the software must comply with ESIGN Act UETA.
Here are the conditions mentioned under ESIGN ACT & UETA:
Legal Compliance.
The concerned document, contract, should not only adhere to the federal rules but should also clearly mention the terms of signature and content, and the intent of every signer.
Plus, the signers must be made aware that they have an option to get a printed or emailed copy of the electronic contract. All the concerned parties must also check if they need any local approval in order to use a digital signature and they must get the approval.
Read the blog- Benefits of Using eSignly in the Healthcare Industry
User Authentication.
Parties to the contract must deploy a mechanism to authenticate the identity of all the concerned parties to avoid disputes and confusion over whether the party participation in the signing process is an authorised party or not.
Parties can rely on eSignature Solution for Healthcare Professionals that offers features like two-step verification, attempting identity verification questions, etc.
Message Integrity.
The software that is being used to make electronic signatures must have a system to make sure that the integrity of the data and the signatures made on the document stays intact during and after the signing process.
Non-Repudiation.
Once the concerned signatures sign the electronic document, they should not deny their action of making electronic signatures (made with their own will).
To ensure this, e-signatures made under HIPAA rules must be timestamped. There has to be an audit trail reflecting the dates, locations, times, and chain of custody. This will prove in the court of law that the contracts are legally bound and valid and that permission to access or share PHI cannot be argued.
Plus, offering the patient and the other signatories a printed copy of a signed document will make an even stronger case.
Ownership and Control.
Last but not least requirement in the HIPAA rules concerning the use of electronic signatures is related to the copies of signed documents that get stored in the cloud using Electronic Signature software.
To make sure that the integrity of patient health records is intact, all the proofs backing the use of electronic signature must be available on the same document under the control, management and ownership of the concerned entity. All other copies, including those given to the singers, must be destroyed digitally unless the entity has signed an agreement with the signature solution company saying otherwise.
To wrap it up:
Deploying Digital Signature for Government Agencies or eSignature Solution for Healthcare Professionals has its own benefits but it can also add to mistakes and risk.
Hence, it is crucial that all the covered parties to the agreement conduct a risk assessment before installing and using electronic signature software under HIPAA. Every rule or regulation is made to ensure the safety of the involved parties and the data they exchanged or the money they transacted.
Hence, it is important to follow the laws of the land and rules of the sector to ensure that every action has taken place and every party involved in the signing process is verified, valid and the process is successful.
Rules might look like hurdles to many, but a smart person will always abide by them.
