The federal government has developed laws to regulate how electronic signing works in healthcare

24 Aug

One can see a positive increase in the use of e signature or electronic signature software in both business and government organizations.

Though there are some industries that are exempted from the legal framework (related to the use of digital signature), many of the industries are enjoying the benefits of a digital signature. Let us take an example of the healthcare sector. It is one of the most benefited industries when it comes to the use of eSignature healthcare solutions. Streamlining day to day operations has become possible with the use of eSignature solutions for healthcare professionals.

If you look at any health organization or medical set up, there is a lot of paper involved. Forms to fill, sign, share, get approved for further treatment, insurance, etc. These activities are of the utmost importance from the singers’ point of view as much as they are important to the government and the concerned parties. Time management and security play an important role in the healthcare sector as it deals with personal client data on a regular basis.

It becomes vital and inevitable to check if all the required and respective precautionary measures are implemented effectively to get rid of errors, delays, and a need for tampering with the personal data of the patients such as medical prescription, intake form, and more. To sort of such a complex work-flow, record and data management efforts are being made. Deploying e-signature solutions in the healthcare industry would contribute to these efforts to boost administrative efficiency. Some countries have issued mandates to protect the digital records of the patients.

All the institutions/organizations or entities which are operating in the healthcare sector are permitted by law to use digital signatures only if they adhere to the required HIPAA rules as confirmed by the HIPAA Act of the federal government.

Apart from the healthcare sector use of digital signature for government agencies is increasing too. The use mainly dominates the following:

  • Filing an application/form/document with any government body or any entity operating under the government rules.
  • Issue of certificate/license/sanctions by the respective governing body. Acceptance, or payment of money/insurance amount/bill, etc from or to the authorized/official individual or institution ruled by the government.

Regulations governing the use of an eSignature solution for government agencies, especially the healthcare sector.

The Healthcare Industry

E-signatures or digital signatures are allowed/accepted legally for most of the healthcare entities by the federal government provided the entity conforms to the given regulations. Any digital signature utilized in any healthcare entity would be considered valid only if it is adhering to the mandates. Some of the requirements are as per the following:

  • Accurate and proper user authentication.
  • Post-signature modifications are prohibited.
  • Storage of the audit trail to allow end-to-end reconstruction of the signature process.
  • Recording, storing, and retaining the proof that the given document is signed digitally.
  • Safe and secured storage of the data.

Before we go ahead and see the rules in detail, let us understand the importance of eSignature Solution for Healthcare Professionals.

Improved Accuracy

A perfect digital signature solution will allow patients to upload and download forms electronically, plus the healthcare entities are assured that the documents are legible. A user-friendly solution would notify the concerned parties once the document is signed.

Time-Saving

Making and collecting digital signatures for every required document becomes easier and faster. Plus the signer can sign from anywhere at any time. An easy to use digital signature solution also saves time with simple features.

Improved Security

A digital solution facilitates electronic procedures and hence physical paperwork is reduced or eliminated. There is no scope for documents to get lost/misplaced or misused. 

Cost-Effective

A digital signature is a cost-effective way of moving ahead towards the future with a seamless workflow facilitating automation of the processes.

Regulations Governing E-signature. 

The healthcare industry is governed by a complicated regulatory framework. The American Congress tried to bring uniformity in the healthcare sector by passing Electronic Signatures in Global and National Commerce Act. This law primarily preempts state laws ruling e-commerce. The aim of this law is to help electronic commerce by removing unnecessary legal hurdles.

Apart from E-SIGN, there are other laws that govern electronic records, and signatures used in the healthcare sector:

  1. The Uniform Electronic Transactions Act (UEAT) passed by the National Conference of Commissioners on Uniform State Laws.
  2. The Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Read the blog- Electronic Signature’s Role in Medical Industry

E-SIGN

E-sign provides that, irrespective of any statute, rules, or other laws governing any transaction (domestic or foreign), a signature may not be rejected to have a legal effect merely because it is an electronic signature. 

E-SIGN ACT talks on how these records can be stored and maintained in the electronic form. If any document is required to be maintained as per the guidelines maintained by the law of the land, an electronic document will be acceptable only if the document is the accurate reflection of the information in the record and the document is accessible to all the relevant parties. The act does not emphasize on using any particular form of technology to use/access digital signatures.

The act defines "electronic" as a technology that has magnetic, electrical, wireless, digital, or other similar features. The same act defines "transaction" as an action/actions which conduct the business/consumer/commercial process between two or more parties. The concept of "electronic record" means a contract/record made, shared, sent, accepted/received, or stored/maintained through electronic means. E-SIGN exempts some records from its regulations.

As per the E-SIGN, "electronic signature" can be any electronic action, process, sound, or symbol that is attached to or is associated with a contract/record and is executed or adopted by a person with an intention of signing the contract. 

The concerned parties can decide the methods of authentication as per their needs, suitability, and concerns. HIPAA and UETA talk in detail about the guidelines that validate the authenticity of e signatures.

E-SIGN defines the concept of the "consumer" as an individual who accepts/receives or obtains, (through a transaction) products or services that are used predominantly with a household, personal, family objective. 


E-SIGN mandates or special requirements are applicable to anyone who is obligated to provide consumers with written disclosures. These requirements are imposed to make sure that the consumers are making an informed decision about indulging in electronic transactions. The act provides security to consumers.

E-SIGN makes sure that the consumer has given consent to receive the required data/record through an electronic medium. The law recommends that before giving consent, consumers must clearly know all the information about their rights as consumers in order to receive information on paper. Such as their right to withdraw consent and the procedures to follow for this; If the consent was given is to any specific transaction or range of transactions or some categories of records; How to get all the records in the paper form, etc.

However, as we have seen before, this act does not cover everything from scratch to end. Hence, it is important to know about other acts that govern digital signatures in the healthcare sector.

HIPAA (Health Insurance Portability and Accountability Act)

The initial concern of this act was to provide improved health insurance for the workers and their families (in America). But HIPAA had one more goal; it was to cut down the administrative burden and expenses of healthcare by defining uniform standards governing healthcare data and electronic healthcare transactions. This section of HIPAA that governs the electronic healthcare transactions is called "administrative simplification provisions of HIPAA." HIPAA has given an extensive set of rules regarding electronic signatures, concerned privacy, and safety in healthcare transactions. 

HIPAA is applicable to health plans, clearinghouses, or healthcare services providers who transfer any confidential health data (in electronic form) in connection with the transactions that are covered in HIPAA. 

Under HIPAA regulations:

"Transaction" means any exchange of information between the concerned parties to conduct or fulfill the concerned financial and administrative actions that are related to healthcare. This usually covers:

Health claims;

Healthcare-related payments;

Benefits;

Signing up or canceling health plan;

Premium payments (of health plans);

Referral certifications and authorizations.

HIPAA forestalls state laws (which contradict), with a few exceptions. 

Exceptions are recognized for state laws that are more strict than HIPAA or the Secretary of the Department of HHS (Health and Human Services) believes that state law is crucial.

“Electronic Signatures” under HIPAA are defined as the attributes that are crucial for the electronic document to emphasize its connection with a particular party. HIPAA does not recommend any specific digital technology as a mandatory technology to authenticate electronic signatures.

UETA (Uniform Electronic Transactions Act)

Apart from the above laws, there is one state law that affects the use of digital/electronic signatures in healthcare transactions. That law is the UETA (Uniform Electronic Transactions Act). The law clearly states that as long as the parties involved in the transaction/contract agree to the electronic transaction, a signature will not be denied a legal backing just because it is in a digital form. Hence, such a contract will be considered legal.

So far 23 states have accepted UETA in some form. This law is in alignment with E-SIGN rules.

Summary

The healthcare sector bears huge expenses to handle, gather, collect, maintain, store, and share the information of every patient and parties related to it. A digital signature is one of the effective solutions that can help in boosting the workflow, assuring safety, and of course, reducing the cost. Healthcare entities and the digital signature solutions provider will have to adhere to the mentioned laws in order to serve their patients better and increase productivity.

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