A medical app development company has to play by a lot of rules to stay compliant
As we’ve mentioned before, there are a range of compliance issues that a medical app development company needs to keep in mind when developing software in the healthcare field. The recent guidance issued by the FDA has clarified some areas of confusion. But privacy laws are still a key concern. This is particularly true for Telemedicine, mHealth, and EHR apps that collect, store, distribute, or convey private health information (PHI).
States Outpace Federal Law in Patient Protection
HIPAA regulations are strict and complex. But there’s another area of privacy law that can come into play as well. The State of Texas has its own set of privacy regulations. From the Texas Attorney General’s website: “Effective September 1, 2012, the Texas Medical Records Privacy Act provides additional protections to consumers. The Act is broader in scope than HIPAA because it applies not only to health care providers, health plans and other entities that process health insurance claims but also to any individual, business, or organization that obtains, stores, or possesses PHI as well as their agents, employees and contractors if they create, receive, obtain, use or transmit PHI.”
Others states also have laws that go above and beyond HIPAA. For example, California state law specify that privacy regulations apply to: “any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information.” Businesses that operate in more than one state need to know and understand the health privacy implications of their healthcare software in each jurisdiction.
At Ayoka, we take the time to fully explore the legal implications of building a medical application and consult closely with our clients to ensure full compliance with state and federal PHI regulations. Contact us at 817-210-4042 to discuss your healthcare software project.