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
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.
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?
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?
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?
This list provides an excellent starting point for vetting a telehealth solution.
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.