Since its first release in 1996, the Health Insurance Portability and Accountability Act (HIPAA) has undergone various changes. This is actually why software development in the healthcare industry is limited by numerous requirements from regulatory medical organizations. With this in mind, how does one develop HIPAA compliant software?
According to a report by Redspin, the world faced 325 large patient health information (PHI) breaches in 2016, with 81% of these cases occurring due to hacking attacks or errors in IT systems. In the healthcare sector, a 10% growth in the frequency of data breaches has been recorded since 2015. The KPMG 2017 Cyber Healthcare & Life Sciences Survey shows that 47% of healthcare organizations have experienced at least one HIPAA data breach in the past two years, compared to 37% in 2015; however, medical organizations have become more prepared for data breaches over the past two years.
Caregivers were asked whether they could manage the situation if a HIPAA data breach occurred. Unfortunately, only 16% of organizations answered that they were completely prepared for a breach in 2015. The following year, 35% of medical organizations answered that they were prepared, if an issue occurred.
What is HIPAA Compliance?
HIPAA is the Health Insurance Portability and Accountability Act, released in 1996, that represents numerous rules and standards created to protect patient health data in any form. Each organization or company that works with PHI must do its best to ensure complete PHI security and implement all possible measures to meet HIPAA requirements. Furthermore, any organization that provides patients with operations and treatments, request payments or works alongside business associates in the healthcare sector who can access PHI, must be HIPAA compliant.
HIPAA Compliance Requirements
Electronic PHI storage solutions have numerous advantages over traditional paper-based methods. Virtual databases allow for increased usability, mobility, and efficiency when it comes to how data is processed; however, electronic methods create additional risks that make healthcare providers implement modern tools and techniques for digital information protection.
The HIPAA rules:
- Privacy Rule;
- Security Rule;
- Enforcement Rule;
- Breach Notification Rule; and,
- Omnibus Rule.
PHI data breaches almost always lead to financial loss, regardless of the number of records stolen. Even a small human error can cause a massive data breach which hackers can take advantage of. Criminals often steal PHI in order to sell it: phone numbers, addresses, and medical records are all precious for them; however, going public is not the most damaging risk for PHI.
Modifying patient’s clinical history, medical records, and certain diagnoses can lead to further incorrect treatment prescriptions. As a result, there is much more room for personal damage and negative health effects that can be caused by inappropriate diagnoses and prescriptions.
The HIPAA Privacy Rule
The final edition of the HIPAA Privacy Rule represents requirements regarding PHI protection. Clinical history, diagnosis, medical records, payments for healthcare treatment, and any other information related to health care must be protected and unavailable to third-parties.
The rule also describes specific conditions under which PHI can be accessed without patient authorization. The HIPAA Privacy Rule includes both limits and patient rights that allow patients to review their personal medical records and request copies. In case of a data mismatch, a patient may request the relevant corrections.
The HIPAA Security Rule
The HIPAA Security Rule describes the requirements of PHI security, including certain recommendations and limits regarding health information security, in order to detect, correct and prevent future security threats. According to this rule, all entities, which have access to PHI (covered entities), must conduct a regular data breach risk analysis to ensure reliable PHI protection. The rule also provides recommendations regarding security risk analysis.
The HIPAA Enforcement Rule
The HIPAA Enforcement Rule covers investigation provisions and details specific financial penalties when a data breach occurs. Penalty amounts depend on the number of medical records disclosed and frequency of data breaches occurred in a specific organization. The “price” of a PHI breach is quite high: from $100 to $50,000 for a first occurrence, and up to $1,500,000 for subsequent breaches.
The Breach Notification Rule
If a data breach involves fewer than 500 individuals, then the healthcare organization has to notify all affected individuals within 60 days after the breach is discovered. The healthcare provider must also inform The Department of Health and Human Services’ Office for Civil Rights about such cases within 60 days of the start of a new calendar year. The report should be made via the OCR Breach reporting web portal.
If a data breach involves more than 500 individuals, media must also be notified.
The Omnibus Rule
The Omnibus Rule was issued on January 25, 2013, and is a rule that modifies and supplements all above-mentioned rules. In general, the changes expand the obligations of physicians and other healthcare professionals regarding PHI protection. The rule mostly impacts business associates.
HIPAA Compliant Software Certification
Unlike PCI compliance for financial information, there is no one that can "certify" organization with HIPAA Compliance Certification. The OCR from the Department of Health and Human Services (HHS) is the federal governing body that oversees HIPAA compliance. HHS does not endorse or recognize "HIPAA Compliance Certifications" made by private organizations. It's up to you to determine if your administrative, technical, and physical safeguards meet HIPAA compliance requirements.
HIPAA Compliance Software Development
In this paragraph, we will consider all the aspects of HIPAA compliant software. The HIPAA Security Rule represents certain safeguards that have become a base for the required features in each software designed for the healthcare sector.
The following is an HIPAA compliance checklist for software developers:
- User authorization;
- Remediation plan;
- Emergency mode;
- Authorization monitoring;
- Data backup;
- Data encryption and decryption;
- Automatic log off;
- Access control.
The following functions will allow you to make your software HIPAA compliant and help medical organizations ensure the security of patient health information stored in an electronic form (ePHI).
The functions required for HIPAA compliant software include:
- Remediation plans;
- Employee training;
- Reliable documentation storage;
- Agreement management; and,
- Incident management.
Let’s consider each function in more detail.
Analyzing HIPAA Security Compliance through Self-Audits
The HIPAA obliges healthcare providers and covered entities to conduct regular audits to test HIPAA compliance in their organizations. HIPAA compliant software must be able to use these audits in order to provide caregivers with a complete picture of how compliant they are. Self-audits generate excellent material for deep machine analysis and risk forecast. They should include questionnaires or assessments that allow for estimation of the current status of a caregiver’s compliance.
Bridging the Gaps through Remediation Plans
The self-audits mentioned above will allow for an understanding of the vulnerabilities in a healthcare provider’s compliance. When these holes are discovered, an effective plan of how to deal with such threats is required. This is where a remediation plan created in advance will come in useful. This is a step-by-step manual covering all the necessary measures that will help prevent PHI data breaches.
As such, a competitive HIPAA compliant software must be able to create and execute remediations plans based on the information entered in self-audits.
Avoiding Data Breaches through 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 created specially for your organization, will help bridge the gaps in your company. In this case, applying generic policies will have no impact in 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.
Preparing for Audits through Secure Documentation Storage
Documentation management is one of the most important functions of the software aimed at the healthcare sector. In fact, using HIPAA compliant software is key, 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. Reliably stored information is perfect proof (and practice) of HIPAA compliance for years to come.
Establishing Reliable Relationships through Agreement Management
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 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.
Efficient Recovery through 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 tremendous fines if there is a data breach. That is why HIPAA compliance software should handle incident recording and analyzing 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.
Reliable and secure software can act as an efficient assistant and gatekeeper for your data, especially for startup owners, financial institutions and, specifically, medical organizations. Adopting an effective solution will facilitate data processing, ensure complete PHI protection, and help avoid data breaches in the future. GearHeart offers deep expertise in building HIPAA compliance software and is ready to provide any healthcare provider or other covered entity with a custom solution that ensures HIPAA requirements are met. Contact us at [email protected] and customize your software as soon as possible!