Understanding Software as a Medical Device

Today’s health software has become so sophisticated that it can now gather patient data to provide clinical guidance useful to medical practitioners. Simple versions of this software can take a few health metrics measured at home or through a wearable device and analyze the data, using known patterns of health and disease to provide some guidance. More complex versions can provide indications of disease, going so far as to suggest further action or even help support a clinical decision.

Finding ways to regulate health software has been an ongoing effort. This July, the FDA finalized its position on low-risk devices, labeling general wellness products exempt from classification or regulation. This includes the software that runs them. But more complex software and devices that contribute to clinical decision support systems are still under consideration. This article explores the benefits of software as a medical device, potential drawbacks, and how using HIPAA and FDA regulations can help address those drawbacks to create safe and reliable tools for more precise medical practice.

Software as a Medical Device: Wellness and Prevention

The FDA considers wearable technologies like fitness trackers and associated software as low risk devices. These tools are aimed at promoting wellness by tracking activity as disease prevention. More intricate software as a medical device does exist and those are used to help make clinical decisions.

For instance, clinical decision support systems use software as a medical device. These tools provide medical practitioners with a safety net, capable of doing things like being an early warning system for adverse drug reactions. Alerting medical staff to a problem before it becomes severe enough to hinder the patient’s recovery. These advanced tools are apt for regulation and classification in the near future.

The Data Trap

While software as a medical device can be a powerful agent for good, there is also a risk for false advertising or potential for wrongdoing. Any tool that gathers patient data, for instance, can be breached—exposing private information for others to see. While a lot of our data is harmless in most hands, some information can be used for medical discrimination.

Worst case scenario: An insurance company could use it to charge you a higher premium or reject your application to avoid a risky investment. These well-known drawbacks led to the creation of Health Insurance Portability and Accountability Act (HIPAA) to protect sensitive health information. With the rapid evolution of software as a medical device, FDA regulation is around the corner. One strategy to prepare for these new regulations is to meet the requirements listed on HIPAA Security Rule.

Regulating software as a medical device

The FDA classifies medical devices based on the associated risks. There are three classes. Class I devices require the fewest regulatory controls while Class III imposes the most controls. So far, the process of classifying the different kinds of software as a medical device is ongoing.

It is expected, however, that most software as a medical device that attempt to support clinical decisions will require FDA classification. While the exact details are unknown, building software as a medical device with the HIPAA Security Rule in mind is a good strategy to avoid costly regulatory or classification setbacks midway through development.

Staying abreast of the latest developments in FDA regulation and classification can be difficult. To avoid costly mistakes, assign a specific person or team to ensure that your upcoming software as a medical device meets the HIPAA Security Rule during development. Another cost-effective approach is to hire an experienced third-party developer such as Nalashaa Healthcare IT Solutions who regularly build in assessment services to identify and correct security and regulatory gaps.

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Amit Manral

Amit Manral

Amit is a healthcare enthusiast who is passionate about the application of creative ideas to improve the healthcare ecosystem. He has been involved with US healthcare for over a decade and loves to understand the challenges of various stakeholders, impact of regulations on them and figure out ways to leverage technology that will impact business positively.

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