When developing software for the telemedicine space in the United States, adhering to telehealth regulations is of the utmost importance.
One of the most important requirements is ensuring HIPAA compliance.
These requirements ensure that patient privacy is respected and that patient data is protected. As more and more companies, from the local medical office or dental office to full-service healthcare conglomerates or hospitals, move into the telehealth space, knowing that you are on the right side of HIPAA compliance is essential for a healthcare business.
The following is a comprehensive HIPAA compliance checklist for software development. Meeting these requirements will help keep you within federal regulations and ensure that your medical business can safely thrive in the digital world and meets the requirements for HIPAA compliance certification.
What is HIPAA?
To start, let’s take a moment to discuss what HIPAA is and what it means to healthcare businesses and their patients.
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. This federal law was enacted by the US Congress to create a set of national standards that would protect patient health information, or PHI.
The main goal of the Act was to ensure that healthcare entities could never share PHI without patient approval or use PHI for financial gain.
After the enactment of this legislation, the US Department of Health and Human Services established the HIPAA Privacy Rule in order to implement and provide guidelines for HIPAA requirements within the healthcare space.
This Privacy Rule defines all the standards for the use and disclosure of PHI by healthcare entities subject to the rule. It also establishes a set of rights for patients so that they can understand and control their PHI.
One difficulty inherent in developing HIPAA and the Privacy Rule is that PHI, at times, has to be shared. The sharing of patient health information is often an essential part of the diagnostic process, for one. PHI must also be shared between doctors and insurers, as well.
The Privacy Rule sought to find a balance between sharing information and protecting patient rights.
PHI in the Digital Age of Telehealth
Since the advent of telehealth, all of these issues have become even more complex.
Now PHI is shared via the internet and digital files.
The same balance must be found between protecting PHI and facilitating fast, high-quality healthcare. That is why HIPAA compliance is now required in the telemedicine development space.
Does HIPAA Compliance Apply to My Telehealth Business?
HIPAA and the Privacy Rule apply to any of the following entities utilizing telehealth technologies:
Healthcare providers – This applies to health care providers of any size who transmit PHI digitally or via electronic transmissions
Health plans – This applies to any and all organizations that pay the cost of a patient’s medical care. This includes health, dental, prescription, and vision insurers, along with the federal agencies that facilitated Medicare and Medicaid.
Healthcare clearinghouses – This applies to any organization that processes nonstandard information related to a patient into data content (or vice versa.)
Business associates – This applies to any individual or organization that uses or discloses PHI to perform services for a covered entity.
The HIPAA Compliance Checklist: Key Requirements and Best Practices
The following is a basic checklist for ensuring that your PHI-centered software solution meets HIPAA compliance demands. This overview can give you an idea of what you need to achieve. Working in partnership with the right developer is the best way to ensure that our solution is compliant.
User Access
As a first step, assess the user access components of your solution. Ask yourself:
- Does my solution include multi-factor authentication?
- Does my solution require a unique username and password for all user logins?
- Does my solution have restrictions on access related to time, function, application or scope?
- Is a user able to terminate a session instantly?
- Does my solution automatically log off a user after a specified time period?
Audit Protocols
Next, you will need to look at the protocols within your solution that support auditing the software and its use of PHI. Ask yourself:
- Is there HD recording of every session available to create an audit trail?
- Is there a comprehensive way to track system and user activity?
Ensuring Data Integrity
Thirdly, you will need to look into the integrity of the data in your solution. Ask yourself:
- Are there strict controls in place around remote access to the system?
- Does the solution have protocols in place for limiting data corruption?
- Is there a detailed audit process in place that allows you to identify changes and facilitate needed corrections?
Transmitting Data
Finally, you need to take an extra-close look at how your software solution transmits data, including of course PHI. Ask yourself:
- Does my solution include customer configurable encryption?
- Does it include AES 128, 192 and 256-bit modes?
- Is a FIPS 140-2 encryption module established as a system default?
Here are some of the best practices you should consider while ensuring HIPAA compliance:
Appoint Standards for Security Management
Every step taken to protect patient information must be reported. Documentation is part of the HIPAA compliance checklist and brings internal clarity. In other words, it should be the backbone of your HIPAA compliance infrastructure.
Assign People Responsible for HIPAA Compliance
Organizing your IT HIPAA compliance checklist is easier when a specific person or department is in charge. To lead this process, you'll need a privacy officer to manage your compliance plan and ensure you follow all the Privacy and Security rules. This puts all the tasks and regulations in one pair of hands, thus helping you avoid confusion and ensure nothing's overlooked.
Set Up a HIPAA Compliance Management Strategy
Make HIPAA compliance part of your daily organizational routine and plans. Conduct staff training, introduce transparent data privacy protocols, and assess vulnerabilities or risks regularly.
Evaluate Risks
Risk assessment is among the key compliance requirements that help detect weak spots in handling patient data. That said, you'll have to make sure both physical and administrative protective measures are set up and function properly. In case there are any issues, developing a troubleshooting plan will help you quickly fix them.
Ensure Your IT Infrastructure Complies with the Standards
On the technical side of the question, always use strong encryption and tight access controls. As for the physical aspect, secure your offices and equipment storing PHI. For instance, introduce key card access systems and cameras to control who has physical access to sensitive data.
Maintain PHI Handling Technology
Updating software systems for processing and sharing patient data must be critical to your HIPAA compliance checklist. Cybersecurity and regular updates keep your systems and PHI protection strong and your compliance on point.
Examine Violations
If a security violation occurs, investigate the causes and how it went wrong. Most issues happen because of internal negligence or oversights. Once you determine the cause, strengthen controls and enhance security policies to avoid similar cases in the future.
Log Violations and Plans for Remediation
Logging violations and the steps taken to fix them are essential for complying with the HIPAA requirements for software development. Moreover, keeping track of all HIPAA-related activities in one place helps clarify things and easily handle a breach when one occurs. After an audit, outline a troubleshooting plan for every violation you find so that you'll know how to handle them later on.
This list provides an excellent starting point for vetting a telehealth solution.
HIPAA Compliance: Latest Updates and Changes
The newest HIPAA compliance regulations in 2024 include updates to the HIPAA Privacy Rule:
- The reproductive healthcare privacy enhancement that addresses concerns about data sensitivity and patient rights.
- The upcoming HIPAA Privacy Rule changes, safeguarding patient information and clarifying patient rights, particularly concerning data access and sharing.
- An NPRM (Notice of Proposed Rulemaking) that revises the HIPAA Security Rule to modernize security requirements, encompassing contemporary cyber threats and technological changes.
The 2024 HIPAA updates reveal several software development compliance challenges that must be navigated by healthcare providers and organizations. To handle them, consider the following checklist of strategies:
- Running regular risk assessments. Identifying potential vulnerabilities is among the first steps for protecting patient data. Regular risk assessments can help your business and healthcare organizations better prepare for emerging threats and ensure their security measures are strong and effective.
- Updating policies and staff training. The IT HIPAA compliance checklist keeps evolving, and so must the policies and procedures guiding PHI management within healthcare organizations. Updating this documentation and running staff training sessions are essential in maintaining compliance and promoting a data protection culture.
- Leveraging technology for enhanced security. Advanced encryption, safe data storage, and incident response or feedback platforms create the technical backbone to avoid unauthorized access and breaches. Implementing these technologies is a key compliance component, according to the 2024 HIPAA updates.
Facilitating patient access to health information: The 2024 updates are based on setting up user-friendly, transparent processes for patients to access, review, and edit their health information. Healthcare service providers should leverage tools and platforms that facilitate the exercise of their rights under HIPAA.
To make sure that your software qualifies for HIPAA compliance certification, reach out to software development professionals that specialize in telehealth solutions.
S-PRO's professionals will help you develop a roadmap for your PHI-oriented solution that meets HIPAA standards while also facilitating the best in patient and user experience.
HIPAA compliance may seem complex, but with the right steps and right partners, any organization can develop a compliant software solution.