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HIPAA compliance for medical software applications can be a complicated issue to understand. Some eHealth and mHealth apps are subject to HIPAA and medical software regulations issued by the FDA. Others are not. This article has been prepared with relevance to HIPAA and medical software. For information about FDA regulations, please visit the FDA´s “Device Advice” web page.
Are the App Subject to HIPAA Compliance for Medical Software Applications?
This will depend on the nature of the app´s function and what its purpose is. If you build an eHealth or mHealth app that collects personal data about the person using it for the exclusive use of the person using it, the app is not subject to HIPAA compliance for medical software applications.
If, however, the personal data collected will be shared with a medical professional or other HIPAA Covered Entity (a healthcare insurance company for example), then the data is considered to be Protected Health Information and the app needs to be HIPAA compliant.
Complication arise between HIPAA and medical software for personal use if the app is providing a service on behalf of a Covered Entity. If, for example, a doctor asks a patient to wear a portable data collecting device, and the data is later to be shared with the doctor, HIPAA applies.
The Terminology of HIPAA and Medical Software Regulations
For a developer building his or her first eHealth app, the terminology of HIPAA and medical safety regulations can be daunting. An explanation of HIPAA and the medical software regulations that might apply can be found in our HIPAA Compliance Guide. Some of the key terminology is explained below:
What is Protected Health Information?
The term Protected Health Information (often abbreviated to PHI, or ePHI when it is stored or transmitted electronically) relates to eighteen specific factors about a person that could be used to determine their identity. These factors are not necessarily related to the person´s health and include their vehicle license plate number and email address. It is important to understand what data is considered to be PHI in order to determine whether or not the app needs to be HIPAA compliant.
What Does HIPAA Compliant Mean?
In relation to medical software applications, the term HIPAA compliant means that the app meets the technical and physical safeguards of the HIPAA Security Rule. In relation to almost any other circumstances, the term HIPAA compliant means you, the tools you use and the premises you work in comply with all the HIPAA Rules contained within our HIPAA Compliance Guide. Please note; hosting an app in a HIPAA-compliant environment does not make the app HIPAA-compliant.
Am I Business Associate?
A Business Associate is a third-party service provider to a HIPAA Covered Entity who has access to PHI. The only circumstances in which a software developer would be classed as a Business Associate (and therefore subject to all the HIPAA Rules) is if he or she is an independent developer who has been contracted by a Covered Entity to develop a HIPAA-compliant app, and the Covered Entity is sharing PHI with them. In this scenario, the developer is required to sign a Business Associate Agreement stipulating permissible uses and disclosures of the PHI. In all other cases, you are not a Business Associate.
It is Important You Are Properly Informed
If you make no effort to find out whether an eHealth or mHealth app you are developing is subject to HIPAA compliance for medical software applications, you could be liable for significant penalties if the use – or misuse – of the app results in an unauthorized disclosure of PHI. The U.S. Department of Health and Human Services´ Office for Civil Rights can impose fines for breaches of PHI, and – in theory – you could be subject to a penalty for the app not being HIPAA-compliant, even if no breach of PHI occurs.
If you are still unsure about whether or not you are subject to HIPAA compliance for medical software applications, you should seek further advice.
For many medical project managers, the Health Insurance Portability and Accountability Act (HIPAA) is a pain. HIPAA outlines what makes a person eligible for “guaranteed issuing,” a process where health insurance companies are not able to refuse some clients because of a pre-existing health condition.
More importantly for project managers, HIPAA also outlines the standards for keeping health care information secure and the standards for electronic billing and other processes—regardless of if the patient is updating their Facebook and Twitter feed with all the details of their ailments.
Even if they so desperately don’t want to, medical project managers need to pay attention to HIPAA standards because it enforces governmental regulations for patients’ personal healthcare information safety. It therefore has a weighty impact on how project managers set up their data centers and how they use and share that data.
HIPAA-compliance software company TrueVault notes that, while HIPAA is a demanding and complicated process, there are really only four obstacles project managers need to overcome to be compliant:
- Secure patient information from malicious attacks.
- Limit the sharing of patient information.
- Have documentation proving that any business associates are HIPAA compliant (this is otherwise known as a BAA).
- Enforce a training program where employees learn when it is appropriate to share patient information and have safeguards in place limiting who can access certain information.
HIPAA-Compliant Project Management Software
Naturally, HIPAA compliance is a much bigger issue than how one interacts with software or how software interacts with patient information, so no software solution will make your medical facility HIPAA compliant. However, there are some project management software features that can certainly help. These include:
- Tracking which user accessed what information at what time, and what they did with that information.
- Limiting user roles so that users can only see the minimum necessary information for each individual patient.
- Extensive encryption and physical security measures.
- HIPAA-compliant accounting features, if necessary.
- Regular and reliable backups.
Given these requirements, there are no project management software that are specifically HIPAA “covered entities.” With that said, check out these options that could be used for HIPAA compliance.
1. Intuit QuickBase
Intuit QuickBase is an excellent choice for large, established medical facilities and healthcare providers. While offering many traditional project management features—like task delegation, reporting, and communication between team members—Intuit QuickBase can also be paired with Intuit’s HIPAA Admin, Physical and Technical Assessment app, which helps medical businesses manage their processes to meet compliance standards.
Price: Starts at $15 per user per month; price varies by number of users and desired features.
Used Intuit QuickBase? Leave a review!
2. Redbooth
Redbooth On-Premise is an incredibly secure system that medical directors have used for years (some may know Redbooth by its prior name, Teambox). Ken Coburn, CEO and medical director at Health Quality Partners, says, “As a company in the healthcare space, Redbooth On-Premise makes it easier to comply with HIPAA and data privacy standards, so we can include key patient and clinical data in our collaborations to improve care.” With bank-level security, real-time communication, time tracking, and powerful reporting features, Redbooth is a great bet for larger medical companies.
Price: Variable; $150 per month for a team of 10.
Used Redbooth? Leave a review!
3. Projectplace
Security, security, security. Projectplace offers ISO-27001 certified service, has a Norton secure seal and was awarded the Qualys SECURE seal. In other words, no one is going to be breaking into this project information system. Using a simple Kanban system, Projectplace is particularly good at fostering communication between team members and stake holders. And for those concerned about limiting access to secure files, individual users have their own sign-ons and user limitations.
Price: Variable; starts at $29 per month per user.
Used Projectplace? Leave a review!
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4. TenRox
TenRox is a cloud-based software best known for its incredible reporting features. But as far as security goes, it holds its own with an ISO-27001 and AICPA certification, ranking it internationally in terms of secured data. From Gantt charts to budgeting to effort tracking to risk assessment, TenRox is a powerful project management toolbox that would benefit any large medical facility.
Price: Not openly available.
Used Tenrox? Leave a review!
More?
While HIPAA-compliant project management software is difficult to come by, medical project professionals can rely on these four options to keep their sensitive information secure.
Did I miss any project management software solutions that should be on this list? Have you had any experiences with the abovementioned suggestions? Leave your thoughts below!
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