Protecting patient data privacy is not only a regulatory duty; it’s a
moral obligation. The US Health Insurance Portability and
Accountability Act (HIPAA), passed in 1996, established the standards
for protecting identifiable health information. In today’s
environment, any organization that processes protected health
information (PHI) must demonstrate compliance with HIPAA rules.
Nowadays, as the use of software continues to grow and become ever
more pervasive among healthcare providers and developers, the
regulations outlined in HIPAA must be fully met and embraced. Indeed,
delivering HIPAA-compliant software assures patient confidence, avoids
financial penalties, and ensures that the healthcare system's
infrastructure continues to operate smoothly and securely.
This article serves as your guide to best practices for building your
HIPAA-compliant software. From due diligence when designing to
implementation and ongoing management, we will walk you through the
entire process of creating it.
Prior to embarking on further stages of planning and designing your HIPAA-compliant software, you will need to conduct a thorough HIPAA risk assessment, which will:
In order to develop software that complies with HIPAA standards, you should incorporate that requirement into the design step of the software development process. Key considerations include:
Identify key stakeholders and engage them throughout the software development processes, specifically project and stakeholder management. Particularly valuable stakeholders include:
PHI encryption is another critical component of PHI protection. Before transmitting PHI, it must first be encrypted. Encryption alters the data but masks it so that it’s unreadable without the proper decryption key.
Providing appropriate safeguards to protect PHI requires that we use the most conservative encryption standards and protocols available, such as the following guidelines:
Role-Based Access Control (RBAC) is a key mechanism for assigning user roles in healthcare software to allow or deny access to Protected Health Information (PHI) across various platforms used in healthcare. Systems limit users to only access the data required for their job roles and the data they can view. Minimizing access to sensitive information prevents blanket access and improves privacy provisions in healthcare organizations. For instance, a nurse will be allowed access to their patient’s medical records relevant to their duties. In contrast, an admin worker may see only a subset of access for billing purposes. These role-based permissions to PHI are carefully analyzed with distinct organization policies and required HIPAA requirements.
Multi-factor authentication (MFA) provides an additional layer of protection by requiring two or more credential verification factors to access sensitive systems and information. A typical setup requires something that you know, something that you have, and something that you are. The combination of factors could include a password (something that you know) a security token or smartphone (something that you have), or even a fingerprint or facial recognition (something that you are). With MFA, your risk of gaining unauthorized access significantly drops, as a breach of one factor (let’s say, your password) will be held at bay by additional factors of security. In the case of healthcare software, it’s a perfect fit for PHI because it’s available only to those who require it and only when they require it.
This is also very important in maintaining security and staying compliant with HIPAA regulations because semi-annual or quarterly reviews of who has access to what will catch and revoke access permission that should have been revoked long ago. For example, suppose you have a school setting with highly restricted rules about access permissions. In that case, you may have inadvertently assigned access to the health department to a long-term volunteer who has since left your school under questionable circumstances months ago, but was allowed to keep their access rights until a staff member noticed them making duplicate notes in the health records for the staff. Having the ability to utilize automated tools and processes to roll up these permissions can speed up the process considerably.
To maintain compliance and system integrity, healthcare software must be repeatedly security audited and vulnerability assessed. A security audit reviews the organization’s security standards, policies, safeguards, and procedures. It ensures the software follows HIPAA rules and industry best practices. The software has known security vulnerabilities, like having a password that’s too short. A vulnerability assessment identifies such weaknesses in your software, allowing you to fix them before they become a problem. It’s important to conduct these audits and assessments regularly to keep your systems secure and find issues before they result in a system failure. These practices help to make healthcare software more secure and more compliant.
When that information is being monitored in a continuous fashion – rather than after the fact or on a delayed basis – individuals can be notified of potential issues as they happen, and automatic responses can be triggered to address those issues in real-time. Having robust systems in place to track who has access to PHI and when unusual activities occur allows organizations to identify potential intrusions at a time when the incident or attempted breach can be limited, resolved, or contained. Typically, the logs that are generated during the course of operations within a system may be tracked, and the computational model of an intrusion detection system (IDS) might be used to monitor these actions.
The monitoring function is one part of this process that these automated tools considerably improve. This refers to the rapid and effective detection and response that tools excel at. Automated technologies like artificial intelligence and machine learning can help to analyze large amounts of data and detect threats quicker than human counterparts. Automated threat-detection systems can ensure that security teams can keep track of unusual activity, breaches, or vulnerabilities and be able to respond quicker than if it were a manual process. This means using these tools improves screening and security by responding to threats quickly and effectively.
Documentation of compliance efforts should be as robust as feasible, given that HIPAA enumerates its requirements in great detail. While also serving to keep individuals working in organizations on their toes, it puts organizations in a position to engage with the spirit of the regulation fully, and – very importantly in today’s world where failures in protecting data can make or break a reputation – to prove that they take these responsibilities seriously. Documentation should consistently record an organization’s security policies, risk assessments, the security activities undertaken to protect PHI, the dates and times of training sessions and audits, and when and how security breaches occurred and were resolved. Detailed documentation results in a useful audit trail of an organization’s efforts toward proof of compliance and provides a clear reference for management and improvement.
Another critical HIPAA compliance goal is developing strong policies for the privacy and security of the data. These policies should be written out, and procedures for data encryption, access authorizations, and secure data handling should be stated. Obviously and logically, policies should be written in a way that staff can understand and are easily accessible by personnel. Policies are excellent procedures only if everyone adheres to them, and policies should be periodically applied to all personnel in a way that makes these policies part of one’s everyday work life. HIPAA compliance must be more than form and ritual.
HIPAA regulations (and the threat of hackers) are ever-changing, and this also means that over time, it’s important to periodically review and update data privacy and security policies. By doing so, policies will remain in line with changes in regulatory requirements, technical capabilities, and emerging threats. This could require additional work, but policies should be updated in response to changes in regulatory requirements, feedback from audits, and lessons learned from security incidents and investigations. Being proactive in policy management helps ensure that the organization remains in compliance with HIPAA, improves the organization's security posture, and better defends PHI against cyber breaches.
Before any healthcare software is deployed, we must ensure it passes all the required tests concerning HIPAA compliance. The process is complex, but all healthcare software applications must be thoroughly vetted for HIPAA compliance before fully launching. Developers should review whether the software works correctly, applies appropriate security controls, and conforms to HIPAA requirements. The questions should be: How the software provides control and stealability of PHI. How does the software verify if the headers containing PHI are encrypted, not just encrypted ones? How the software controls access to the preventative, treatment, and administrative information associated with the patient. All these questions must meet HIPAA requirements for perfect security, privacy, and confidentiality controls.
Penetration tests and security assessments of healthcare software are crucial to identifying how vulnerable your healthcare software may be to a breach. Penetration tests, or pen tests, simulate attacks to assess how well the software would resist attempts to exploit vulnerabilities. Security assessments entail a detailed review of the code architecture, configuration, and inherent security qualities to rank the level of risk and advise on changes. Pen tests and security assessments should be done periodically, and changes should be made to the software at any time. Safety checks should include analyzing the capacity of personnel and potential hackers to insert malicious codes into the treated data. Any vulnerabilities found through penetration tests or security assessments should be fixed immediately.
HIPAA-compliant software is necessary to keep protected health information (PHI) safe and secure so everyone remains quiet. Protecting sensitive health information can be achieved by following best practices such as conducting timely risk assessments, ensuring robust encryption, establishing access controls, and more. To provide an undisrupted and enjoyable experience, developers can continuously monitor and perform regression testing. To keep the environment secure and compliant, frequent reviews and updates of the policies will happen, while regular interval testing of the system and people ensures that data privacy and security are maintained.