Are you familiar with the Health Insurance Portability and Accountability Act (HIPAA)? If you’re, for example, a digital health company that handles medical records and works in the US, it’s crucial that you’re aware of this legislation. HIPAA has been in effect since 1996 and aims to safeguard patients’ sensitive data from any potential mishandling or misuse. In this article, we will provide you with a comprehensive understanding of HIPAA’s importance, along with a HIPAA compliance checklist for software development. Keep reading to learn more about how custom healthcare software can enhance your health information technology.
What Is HIPAA?
HIPAA is a federal law enacted in 1996 that aims to prevent the unauthorized disclosure of sensitive medical data about patients without their knowledge or consent. The law requires national regulations to be established to enforce these standards. The US Department of Health and Human Services (HHS) has published the HIPAA Privacy Rule to ensure that covered entities comply with the standards. In addition, the HIPAA Security Rule provides protection for a subset of the data that is safeguarded under the Privacy Rule. Healthcare organizations must integrate HIPAA regulations into their existing operations to maintain the confidentiality, security, and integrity of protected health information (PHI) through a network of interconnected legal requirements to remain compliant.
Okay, And What Is PHI?
PHI includes any demographic data that can be used to pinpoint a patient or consumer of a HIPAA-compliant entity. Examples of PHI include personal identifiers, residential addresses, contact details, Social Security numbers, medical histories, payment records, and full-face pictures. PHI that is electronically transmitted, stored, or received is also subject to HIPAA regulations and is known as electronic protected health information (ePHI). The HIPAA Security Rule governs ePHI, which was added to the HIPAA regulations to keep up with advancements in medical technology.
Who Is Needed to Be HIPAA-Compliant?
Contrary to popular belief, HIPAA compliance isn’t solely required by healthcare providers and institutions. The HIPAA clinical health act distinguishes between two types of organizations that must follow this law: covered entities (CEs) and business associates (BAs). Covered entities encompass organizations that electronically receive, generate, or distribute PHI, such as healthcare providers, insurance ones, and intermediaries. Meanwhile, business associates are companies that handle PHI in any capacity while providing services on behalf of a covered entity. Examples of business associates affected by HIPAA laws include billing companies, practice management organizations, third-party advisors, EHR providers, MSPs, IT services, etc.
Welcome: HIPAA-Compliant Software
Now that we have covered what HIPAA compliance and PHI are, as well as who should be involved, let’s shift our focus to HIPAA-compliant software. However, before we dive into the specifics of this type of medical software, let’s address a crucial point. Despite the widespread sentiment, there is no such thing as “HIPAA-compliant software.” This term typically refers to software that has been modified to make your organization, your colleagues, and yourself HIPAA-compliant.
One of the examples of that is a cloud-based medical records management system that uses encryption to securely store patient data. The software has a role-based access control system that ensures only authorized personnel have access to patient information. It also includes audit trails that track who accessed the data, when, and what changes were made. In addition, the system allows for secure communication between healthcare providers and patients and includes features for appointment scheduling and prescription management, all while maintaining HIPAA compliance.
With that said, let’s explore the importance of HIPAA compliance in software. HIPAA-compliant software adheres to all of the rules for the secure handling of patients’ PHI. The goal of this software is to provide a framework that assists covered entities or business associates in achieving HIPAA compliance and maintaining ongoing adherence to its regulations.
Why is building HIPAA-compliant software so crucial?
Protecting Patient Privacy: HIPAA-compliant software is designed to protect the privacy of patients by ensuring that their sensitive health information is kept secure and confidential.
Avoiding Penalties & Legal Issues: HIPAA violations can result in significant financial penalties, damage to reputation, and loss of trust by patients. Developing HIPAA-compliant software can help healthcare organizations avoid these issues.
Building Trust with Patients: Patients expect their healthcare providers to keep their sensitive health information safe and secure. By using HIPAA-compliant software, healthcare organizations can build trust with their patients by demonstrating their commitment to protecting their privacy.
Meeting Regulatory Requirements: HIPAA applies to covered entities such as healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that handle patient data on their behalf. Developing HIPAA-compliant software is necessary for healthcare organizations to meet these regulatory requirements.
Improving Data Security: Developing HIPAA-compliant software requires implementing security measures such as encryption, access controls, and audit trails. These security measures not only protect patient data but also improve the overall security of the software.
HIPAA Compliance Rules
HIPAA-compliant software development methods are defined by legislative laws and regulations that establish the necessary requirements for the secure handling of electronic PHI. Before we discuss the software checklist, it’s important to understand the mandatory rules that govern HIPAA compliance:
HIPAA Privacy Rule: It sets national guidelines for patient access to PHI and applies only to covered entities. It specifies requirements such as patients’ ability to view PHI, healthcare providers’ ability to limit access to PHI, and the contents of Use and Disclosure HIPAA release forms and Notices of Privacy Practices. Proper policies must be established in the business’s HIPAA Policies and Procedures, with all personnel trained and documented annually.
HIPAA Security Rule: It sets national standards for the secure storage, transfer, and management of ePHI and applies to both covered entities and business associates. It establishes criteria for the security and confidentiality of ePHI, including structural, organizational, and technical measures that must be implemented in every healthcare institution. The regulation’s details must be specified in the organization’s HIPAA Policies and Procedures, with employees trained and documented annually.
HIPAA Enforcement Rule: It outlines the requirements for data breach investigations and massive fines, with the amount fluctuating depending on the number of medical records compromised and the degree of information breaches. A first-time breach can result in a company spending anywhere from $100 to $50,000, while consecutive breaches can cost up to $1.5 million.
HIPAA Breach Notification Rule: It sets guidelines that covered entities and business associates must follow in the event of a data breach involving PHI or ePHI. It specifies varying rules for breach reporting based on the extent and severity of the incident. Companies must disclose all breaches, regardless of magnitude, to HHS OCR, but reporting methods vary based on the nature of the breach.
HIPAA Omnibus Rule: This rule is an extension of HIPAA regulations created to apply HIPAA to business partners and sets standards for Business Associate Agreements (BAAs). Before PHI or ePHI can be transmitted or exchanged, a covered entity and a business associate, or two business associates, must sign a BAA. The Omnibus Rule was introduced in January 2013 and reinforces previously specified standards.
Software Development & HIPAA Compliance Checklist
Ensuring the security and confidentiality of patient data is a critical aspect of HIPAA compliance. HIPAA regulations outline specific guidelines for maintaining patient data confidentiality and reporting data breaches. Therefore, it is important to configure your software in a manner that complies with these regulations. To assist with HIPAA-compliant software development, the following checklist can be used.
The User Authorization component of HIPAA compliance refers to the policies and procedures that CEs and BAs must follow to ensure that only authorized users have access to PHI.
Some of the key aspects of user authorization in HIPAA compliance include:
Access Controls: CEs and BAs must implement technical safeguards to ensure that only authorized users can access PHI. This may include password-protected access controls, multi-factor authentication, and other measures to prevent unauthorized access to PHI.
Role-Based Access: CEs and BAs must implement policies and procedures that restrict access to PHI based on an individual’s role within the organization. For example, a physician may have access to more PHI than a receptionist or administrative staff member.
User Training: CEs and BAs must provide training to all employees on the proper handling and protection of PHI. This includes training on user authorization policies and procedures, as well as best practices for data security and privacy.
Audit Controls: CEs and BAs must implement systems to track and monitor user access to PHI. This includes logging access attempts, monitoring user activity, and implementing audit controls to ensure that unauthorized access attempts are detected and reported.
Today’s best practice is MFA — Multi-Factor Authentication — which is a security mechanism that requires users to provide two or more different authentication factors to gain access to a system or application. It is considered a reasonable and appropriate technical safeguard that can help mitigate the risk of unauthorized access to PHI.
The remediation plan is a critical security strategy that outlines the steps taken by business associates to protect patient information, including adherence to industry standards for security. This plan encompasses several key factors:
Notification: The CE or BA must promptly notify affected individuals, HHS, and, in some cases, the media, of the breach.
Investigation: The CE or BA must conduct a thorough investigation of the breach to determine the scope of the incident, the cause, and any corrective actions that need to be taken.
Mitigation: The CE or BA must take steps to mitigate any harm to individuals whose PHI may have been compromised. This may include offering credit monitoring services, providing free identity theft protection, or offering other forms of assistance.
Corrective Action: The CE or BA must take corrective action to prevent similar breaches from occurring in the future. This may include implementing additional security measures, revising policies and procedures, or providing additional training to employees.
Documentation: The CE or BA must document all aspects of the breach, including the notification process, the investigation, the mitigation efforts, and any corrective actions taken.
An organization’s response to emergencies is guided by its emergency mode plan. This plan outlines the procedures, responsibilities, and standards for safeguarding medical records in case of emergencies. Therefore, the emergency plan for your healthcare application should include the following:
a comprehensive list of all team members, their roles, contact information, and responsibilities;
information on all electronic medical systems used by the organization;
a step-by-step process for implementing the plan, including who will do what and when.
Business associates must identify potential risks and determine the appropriate situations for implementing the plan. This helps improve risk assessments and prepares the organization for a real emergency.
It is crucial for app developers and administrators to regularly test the effectiveness and security of access mechanisms. The following permission preventative measures are integral components of the comprehensive HIPAA compliance checklist for software development:
Audit controls and activity logs: Utilize an automated risk detection program to quickly identify any suspicious attempts to breach the system. Monitoring the activity records of all users allows for the detection of usage patterns.
Automatic log-offs: Healthcare software should be designed to log the user out of the system automatically, reducing the likelihood of profile breaches.
Access control during emergencies: The technology should allow the organization to access a user’s profile in emergency situations, even if their colleagues are not physically present.
One of the HIPAA requirements mandates that all electronic protected health information (ePHI) must be stored on a reliable storage device, necessitating the frequent generation of backups for patient information, data, and images. Data backup is an important aspect of HIPAA compliance, and it involves several key considerations. Firstly, it is important to implement duplication, which involves creating backups of both data and software. To ensure maximum security, it is highly recommended to store cold backups as far away from the origin as possible. This can help protect against risks such as natural disasters, theft, or cyberattacks.
Another important consideration for data backup in HIPAA compliance is encryption. It is crucial to encrypt data at rest when they are located on a storage device such as a cloud server or disk. The most effective encryption algorithm is AES-256, which provides robust protection against unauthorized access.
When it comes to transferring PHI over the Internet, additional security measures are necessary. While AES encryption can provide some protection, it is not sufficient on its own. Therefore, the best practice is to use TLS (Transport Layer Security) protocol. TLS is more secure and complex than regular AES, and it provides enhanced protection for data transfers. The preferred protocol is TLS 1.3, but TLS 1.2 is also widely used. It is important to ensure that all transfers of PHI are conducted using these security protocols to maintain HIPAA compliance.
How to Maintain HIPAA Compliance
Maintaining HIPAA compliance is not just a matter of ticking off items from an EMR HIPAA compliance checklist for medical records. It requires ongoing effort to uphold the standards and guidelines. Here are five simple tips to help you stay compliant if you are subject to the law.
Understand Key Terminology
HIPAA uses many technical terms with specific definitions. To ensure compliance, it is important to have a thorough understanding of their meanings. For example, “confidential handling of PHI” refers to using appropriate administrative, technical, and physical security measures.
Create Duplicates of Patient Records
HIPAA-covered organizations, particularly medical practices, are required to create and maintain identical copies of electronic PHI.
Store Backup Electronic PHI Separately
HIPAA mandates that backup copies of electronic PHI be stored in a separate location from the primary data storage, and must also be encrypted to meet security requirements.
Ensure Your Backup Solution Provider is HIPAA Compliant
By implementing necessary administrative, technical, and physical safeguards to ensure the security, integrity, and availability of PHI, you can verify that your backup provider meets HIPAA compliance standards.
Sign a “Business Associate Agreement”
HIPAA requires covered entities to enter into contracts with their “business associates,” which include anyone who creates, receives, or maintains PHI on behalf of the covered entity. Backup providers fall into this category and are required to sign Business Associate Agreements with their clients.
Non-compliance with HIPAA guidelines is a severe offense, and failure to ensure HIPAA-compliant software can land you in hot water. Common violations include lost or stolen laptops, mobile devices, and USBs, malware attacks, workplace theft, releasing PHI to the wrong recipient, discussing PHI outside the workplace, and posting PHI on social media. It is important to note that each of these infractions must be linked to the breach of HIPAA-protected health information in some way. However, it is crucial to consider that every company is unique when addressing common HIPAA violations.
Although it may seem daunting to comply with federal law, you now have all the necessary information on how to ensure your healthcare software is compliant. Regardless of whether you work in the healthcare industry, it is crucial to prioritize the security of sensitive medical data. Patient health records must be kept with the highest level of confidentiality, and hiring healthcare software developers can assist you in achieving this. If you want to create HIPAA-compliant software, get in touch with us today to steer your company in the right direction.
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