How to Make Custom Healthcare Software HIPAA Compliant ?

Updated on Apr 9th, 2024

How to Make Custom Healthcare Software HIPAA Compliant

2019 recorded 510 healthcare data breaches where 41.11 million records were exposed, stolen, or impermissibly disclosed. That equates to 42.5 data breaches per month wherein the industry now accounts for over four out of every five data breaches. Although January’s figures are a terrific improvement with a reporting rate of 1.03 violations per day, 2020 is expected to be another ground-breaking year with data breaches cost expected to reach $4 billion. Primary causes include data theft, improper disposal, unauthorized access or disclosure, and hackling or IT incidents. 

While there could be multiple outcomes of these data breaches, some of the instances could be life-threatening. But, is there a way to deal with these breaches? If so, what?

HIPAA is the answer. Let’s understand various aspects of HIPAA and how you can ensure data security by implementing the guidelines.

What is HIPAA Compliance? 

Hipaa compliance

The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient information. Healthcare services that deal with protected health information (PHI) MUST have the physical, network, and processes security measures in place and follow them strictly to ensure HIPAA compliance. In addition to this, covered entities such as clinicians or anyone who is treating the patient, payments, and operations in the healthcare organization along with the business associated who have access to patient records or assists treatment, payment, or services must meet the HIPAA compliance. Not just this, even the contractors and subcontractors or business associates must also be in accordance.

What are the Requirements of HIPAA Compliance?

Arguably, Electronic PHIs offers a much better approach to paper-based methods. Having virtual databases allows for increases usability, mobility, and efficiency during data processing. However, they also pose some additional risks that make it essential for one to implement the advanced tools and techniques for digital information protection. PHI data breaches can not just cause substantial financial losses to the healthcare organizations, but can also open data for disastrous outcomes. Small human error can expose critical health information along with other personal patient records to the cybercriminals who may make information like phone numbers, addresses, medical records, etc. public. But that’s not it. They can also modify the patient records within the system that can cause incorrect treatment and, consequently, can be life-threatening. Therefore, there’s room for personal damage as well as inappropriate diagnosis and treatment.

Here is how various HIPAA rules help protect vital information and eliminate the chances of data breaches.

What are the HIPAA Rules?

1. The HIPAA Privacy Rule
2. The HIPAA Security Rule
3. The HIPAA Enforcement Rule
4. The Breach Notification Rule
5. The Omnibus Rule

1. The HIPAA Privacy Rule

The HIPAA Privacy Rule talks about PHI protection. It states that patient records like clinical history, diagnosis, medical records, payment made for the treatment, and other vital information must be protected with advanced tools and technologies and under no circumstances should be made available to the third-parties.  

It also clearly mentions the conditions under which the records can be accessed without the patient’s authorization. Therefore, it includes the limits as well as patient rights that let patients review their personal medical records and request copies. In case the data mismatches to ideal values, patients can request relevant corrections.

2. The HIPAA Security Rule

According to the HIPAA Security Rule, it is mandatory for all the entities who have access to PHI, including the covered entities, should run regular data breach risk analysis to ensure reliable PHI protection. It also states guidelines about security risk analysis. It describes the requirements of PHI security, including certain limitations and recommendations regarding health information security for detecting, correcting, and preventing future security threats.

3. The HIPAA Enforcement Rule

HIPAA Enforcement Rules covers investigation provisions and details specific financial penalties in conditions of data breaches. Penalty amounts depend on the number of medical records disclose and the frequency of data breaches occurring in a particular organization. It can range from $100 to $50,000 for the first occurrence and go up to $1,500,000 for the subsequent breaches.

4. The Breach Notification Rule

It states various rules for notifying the individuals and authorities about the breach. If the data breach involves less than 500 individuals, then the healthcare organization has to inform all the affected individuals within the 60 days of the breach discovery. In case there are more than 500 people involved, the media must also be notified. Healthcare services have to inform the Department of Health and Human Services’ office for civil rights about such cases within the next 60 days of the start of the new cycle. They can report the same via the OCR Breach reporting website.

5. The Omnibus Rule

This rule basically impacts the business associates and came into effect on 25 January 2013. This rule modifies and supplements all the previously available rules. In general, the changes expand the obligations of physicians and other healthcare professionals regarding PHI protection.

How can You Become HIPAA Compliant? 

Here are some steps that you are supposed to take if you want to become HIPAA compliant.

Step 1: Analyse the Current HIPAA Security Compliance Status with Self-Audits

As stated, HIPAA obliges healthcare organizations and covered entities to conduct regular surveys to ensure HIPAA compliance. Custom software must be able to use these audits to provide healthcare entities with a comprehensive view of their compliance level. Additionally, self-audits generate excellent material for in-depth machine analysis and risk forecasts.

Step 2: Fill the Gaps through Remediation Measures

Self-audits get you a clear picture enabling you to understand vulnerabilities in your compliance. Once you identify the shortfalls, you need to workout an effective plan on dealing with it. And that’s precisely where a redemption plan created in advance will come handy. 

The custom software you create must be able to create and execute remediation plans based on the information derived from self-audits.

Step 3: Take Control of Data Breaches with Employee Training

Once the vulnerabilities are identified, and the appropriate remediation plans are created, it is time to conduct the measures that will help avoid human error. Custom policies and procedures, which are designed especially for your organization, will help bridge the gaps in your company. In this case, applying generic strategies will have no impact on your particular business.

Blinders do not address the specialties of your organization and do not take your existing systems into account; therefore, your HIPAA compliant software should help you develop convenient procedures and policies in order to avoid PHI breaches.

Moreover, the software must contain effective employee training programs that will help your staff become aware of cyber threats, the possible consequences of data breaches, and learn how they can ensure additional PHI security.

Step 4: Preparing Audits through Secure Documentation

Documentation management is one of the essential functions of the software aimed at the healthcare sector. In fact, using HIPAA compliant software is vital, as its main advantages include secure storage and structured documentation management. The software simplifies documentation processing and makes caregivers completely ready for any kind of unexpected audit. The reliably stored information is perfect proof (and practice) of HIPAA compliance for years to come.

Step 5: Agreement Management with HIPAA Compliant Healthcare Software Development Company

The HIPAA regulates relationships between caregivers and their business associates that are organizations hired to handle ePHI. The Omnibus Rule mandates business associate agreements (BAAs) made between healthcare providers and their business associates. That is why the adopted software has to manage these relationships and allow them to execute BAAs when needed. Furthermore, the solution must track the signing of the agreement by all business associates and monitor the way they handle ePHI to ensure you work with a reliable partner.

Also Read- Everything You Need to Know about Healthcare Software Development

Step 6: Recover the System Efficiently via Incident Management

All healthcare providers and covered entities always risk disclosing medical records and violating HIPAA principles. An opened laptop or broken safe can lead to huge fines if there is a data breach. That is why HIPAA compliance software should handle incident recording and analysis for you. If the solution could not prevent a specific breach from happening, that error must be analyzed in order to avoid such situations from recurring. Moreover, the software must also automatically report the case to OCR when a breach occurs.

What is HIPAA Compliance Checklist for Healthcare Software Development?

Here are the critical features ensuring which will make sure your software is compliant with HIPAA guidelines.

  • Ensure password-protected system access
  • Access control to be maintained
  • Authorization monitoring by admins
  • Data backup to ensure retrieval
  • Proactive remediation strategy should be ensured
  • Emergency mode
  • Automated log out if the system is not accessed for long
  • Data storage with encryption and decryption

What to Keep in Mind While Making Your Custom Healthcare Software HIPAA-Compliant?

As a matter of fact, HIPAA encompasses all the mHealth applications, as well as the custom software solutions designed for the healthcare units. Here’s what you can do in order to ensure that your software product is HIPAA compliant.

1. Have Defined User Roles

Review the software architecture and make sure you have clearly defined user roles and responsibilities. Make sure you thoroughly check that the data is available to the authorized users only and is disposed of safely.  

2. Minimum Risk and Exposure

Limit the use and sharing of PHI. Make sure no one has access to or can display or store data, which is unnecessary. Avoid storage of cache PHI whenever possible. Additionally, they have provisions for secure PHI data transmission and storage while saving data on the cloud. That typically implies that data collected on the cloud should also be HIPAA compliant.

3. Secure Data Transmission and Storage

Data security via encryption methods helps one stay HIPAA compliant. One needs to use available tools and protocols to encrypt and verify data stored and transmitted.

4. Constantly Validated Security

Make sure that after a certain period of inactivity, the software logs the user out. Additionally, it should be ensured that push notifications containing PHI should never be allowed. Also, avoid storing PHI in backups and highly vulnerable log files, especially while using SD cards in Android devices.

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Matellio- Your Partner in Building HIPAA-Compliant Custom Healthcare Software

At Matellio, we understand the risk associated with data theft as much as we know how critical a good custom healthcare software can be for an organization. Therefore, healthcare providers across the globe trust us for our reliable healthcare technology consulting services. Having partnered with multiple brands, including bug names to startups, we offer an extensive range of services and experience that comes at very cost-effective and time-efficient rates. Want to know more? It’s simple, fill in the form and get started! 


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