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Guide To Building HIPAA-Compliant Software In 2021

calender 07 Dec 2021

“Here is a complete guide that will provide you with general information on HIPAA, its crucial checklist, and how to develop a HIPAA-compliant software.”

What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) sets the norm for delicate patient data protection. Organizations that deal with protected health information (PHI) should have physical, organization, and process security efforts set up and follow them to guarantee HIPAA Compliance.

Covered substances (anybody giving treatment, payment, and activities in medical services) and business partners (any individual who approaches patient data and offers help in treatment, payment, or operations) should meet HIPAA Compliance. Different elements, for example, subcontractors and some other related business partners should likewise comply.

What are the requirements of HIPAA Compliance?

As per the U.S. Department of Health and Human Services (HHS), the HIPAA Privacy Rule, or Standards for Privacy of Individually Identifiable Health Information, sets up public principles for the assurance of specific health information. Also, the Security Rule sets up a national set of security principles for ensuring specific health information that is held or transferred in an electronic structure. 

The Security Rule operationalizes the Privacy Rule's protections by communicating the nontechnical and technical safeguards that canvassed entities should keep a place to secure people's electronic PHI (e-PHI). Inside HHS, the Office for Civil Rights (OCR) is answerable for authorizing the Privacy and Security Rules with deliberate compliance activities along with civil money penalties.


HHS calls attention to that as medical care suppliers and different elements managing PHI move to computerized operations, including computerized physician order entity (CPOE) frameworks, electronic health records (EHR), and radiology, drug store, and research center frameworks, HIPAA compliance is a higher priority than ever.

Essentially, health plans give an approach to claims as well as care management and self-administration applications. While these electronic techniques give expanded effectiveness and mobility, they additionally radically increment the security risks facing healthcare data.

The Security Rule is set up to ensure the protection of people's health data, while simultaneously permitting covered substances to take on innovations to work on the quality and productivity of patient care.

The Security Rule, by configuration, is sufficiently adaptable to permit a covered element to execute policies, strategies, and innovations that are fit to the substance's size, organizational structure, and risks to patients' and buyers' e-PHI.

How to become HIPAA Compliant?

      Create Privacy & Security Policies for the Organization

Becoming HIPAA compliant requires more than essentially keeping HIPAA Security and Privacy Guidelines. Covered entities and business partners should likewise demonstrate that they've been proactive about preventing HIPAA infringement by making protection and security policies. It is essential to keep these policies documented, communicated to staff, and regularly updated. 

      Name a HIPAA Privacy Officer and Security Officer

The HIPAA Security Rule requires covered elements to assign a Privacy Compliance Officer to regulate the development of privacy policies, guarantee those policies are implemented, and update them every year. HHS proposes that bigger organizations also form a Privacy Oversight Committee to assist with directing policy creation and managing oversight.

    Implement Security Safeguards

The Security Rule requires three types of safeguards that covered entities and business associates must have in place to secure ePHI — including:

     Administrative Safeguards

     Physical Safeguards

     Technical Safeguards

     Regularly Conduct Risk Assessments and Self-Audits

     HHS requires covered substances and business partners to conduct ordinary (basically yearly) reviews of all administrative, technical, and physical safeguards to distinguish compliance gaps.

      Maintain Business Associate Agreements

Before offering PHI to business partners, covered entities should get "satisfactory assurances' ' that the business partner is HIPAA-compliant and can successfully protect the information, and the parties should enter a BAA.

      Establish a Breach Notification Protocol

The HIPAA Breach Notification Rule requires covered elements and business partners to report all breaks to OCR and to notify patients whose personal information may have been compromised.

      Document Everything

Organizations should document all HIPAA compliance endeavors — including protection and security policies, risk assessments and self-reviews, remediation plans, and staff instructional sessions. OCR will survey this documentation during HIPAA reviews and complaint investigations.

HIPAA Compliance Software Vs. HIPAA Compliant Software

The expressions "HIPAA compliant software" and "HIPAA compliance software" are now and then utilized conversely by some software sellers, albeit the two terms mean something very unique.

"HIPAA compliance software" is an application or service that directs a business through its compliance endeavors. HIPAA risk assessment software can either assist with explicit elements of HIPAA compliance (for example Security Rule risk assessments) or give an absolute answer for each element of HIPAA compliance.

HIPAA compliant software is generally an application or service for medical care associations that incorporates all the fundamental privacy and security safeguards to meet the necessities of HIPAA, for example, secure messaging solutions, hosting services, and secure cloud storage services. HIPAA compliant software doesn't ensure compliance. It is the obligation of clients of the software solutions to guarantee the software is utilized in a HIPAA-compliant manner.

HIPAA Compliance Software Checklist

To achieve HIPAA compliance software certification adheres to the following checklist:

      User Authorization

The US government orders the degree of identity assurance in software applications into four levels. The lowest levels utilize just a solitary component authentication. In this way, assuming that a client can freely get to the framework with the help of a password though the level of safety is concerning. Higher levels make use of multi-factor authentications wherein users need to verify their mobile phones, email addresses, etc.

To make your software HIPAA-compliant, you need to include at least two of the below-mentioned factors:





      Remediation Plan

The remediation plan is a security plan that subtleties the actions taken by the business partners for patient data protection. So it considers the below-mentioned aspects and documents the safety best practices.

     A list of all the tasks that will be undertaken to ensure data security

     Clear identification of each team member’s responsibility for the same

     Plan of action to overcome challenges in future

      Emergency Mode

An emergency mode plan directs an association's game plan during an attack. It determines the strategies, tasks, and practices to protect the records of the patients during a crisis. Accordingly, this emergency plan of your HIPAA compliant healthcare application should contain the accompanying data:

     A total rundown of all the colleagues alongside their jobs, contact, and obligations.

     Subtleties of all the advanced medical services frameworks that the association employments

     A bit by bit technique for executing the arrangement (how, when, by whom)

     Recuperation techniques

      Authorization Monitoring

The application designers, developers, and owners should take a look at the proficiency and safety of the access algorithms at ordinary time frames. Below mentioned authorization prudent steps are a fundamental part of the total HIPAA compliance checklist for software development:

    Activity logs and audit controls

To make identification of any suspicious attempts easier it's wise to use an automated system of risk detection.   

    Automatic log-offs

Any healthcare software ought to be planned so that a client consequently logs-out from the framework when their shift is over. In this manner, you can reduce the odds of profile penetration.

    Access control in emergencies

The framework should have a choice to allow the organization access the client's profile for a situation of crisis, regardless of whether those colleagues aren't truly present.

      Data Backup

As per this provision of the HIPAA, all electronically protected health information (ePHI) should be copied on reliable data storage. This infers that you should make a reinforcement of the patient details, records, pictures, and so on, consistently. It is significant for the association to focus on the accompanying aspects to make their product HIPAA-compliant:





How To Develop a HIPAA Compliant Web?

A HIPAA-compliant website secures everyone. It makes sure everyone who is part of the patient's care, from web-hosting to data entry protocols and passwords, is safe. In case you are collecting, storing, or communicating any ensured wellbeing data, then, at that point, HIPAA compliance rules concern you and your site.

Here are seven tasks to ensure you have a HIPAA compliant website:

      Start with HIPAA compliant web hosting

      Make sure you have an SSL certificate for your website

      Encrypt and secure all web forms

      Insist on a business associate contract

      Restrict access to PHI

      Develop and implement systems for accepting, storing, transmitting, and deleting PHI

      Provide HIPAA compliance training to everyone with access.

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