Why is HIPAA Compliance Important to Medical Manufacturers?
As advancements in technology and medicine are made, more and more patient health data is being stored and exchanged via high-tech medical devices. While the use of these devices has led to significant improvements in the quality of care and well-being of patients, the information stored and transmitted with these devices includes sensitive patient data that can easily be intercepted without proper security. Because of this, medical devices that store patient data must comply with the Health Insurance Portability and Accountability Act (HIPAA). Designing medical devices to be compliant with HIPAA, however, is more easily said than done. This article will explain what HIPAA is and why it is important to medical device manufacturers.
What is HIPAA?
HIPAA is the acronym for the Health Insurance Portability and Accountability Act. It became US law in 1996. Its purpose is to create a national standard for the protection of sensitive patient health data from entities other than the patients themselves or their authorized representatives while maintaining the flow of information and data necessary for quality care. The US Department of Health and Human Services (HHS) is charged with enforcing HIPAA.
HIPAA contains two rules that help facilitate its implementation: the privacy rule and the security rule.
- The privacy rule
The privacy rule sets standards for the use and disclosure of an individual’s health data, otherwise known as “protected health information,” or PHI, by “covered entities.” Covered entities include healthcare providers, healthcare-related businesses (insurance companies and healthcare clearinghouses), and any business that performs services on behalf of a covered entity (“business associates”). Business associates refer to medical device manufacturers and application developers.
- The security rule
The security rule regulates a subset of the items protected by the privacy rule. It states that any health information created, transmitted, received, or maintained electronically (known as e-PHI) by covered entities must also be protected, and may not be transmitted without the consent of patients or their authorized representatives. Violations of the Act could result in civil or criminal penalties. Patients themselves, however, can retrieve their healthcare information and transmit it as they please.
What is considered protected health information (PHI)?
Any information that contains personally identifiable information about an individual is considered as PHI or e-PHI. This includes items such as names, addresses, e-mail addresses, phone numbers, social security numbers, and demographic information. It also includes health-related information about an individual, such as medical history, test results, medical imaging data, and insurance information.
The semantics of what’s considered PHI can get confusing for designers of medical devices. Many devices, such as blood pressure monitors and weight scales, are manufactured for consumer and home use. Using them does not require a medical professional to be present. These and similar devices are used by individuals to monitor their own health, not on behalf of a covered entity. Therefore, these devices are not subject to HIPAA requirements. Similarly, covered entities can recommend to patients that they use a specific device at home, but these devices are also not subjected to HIPAA regulations since they weren’t manufactured for the covered entity. However, should the data recorded by these home-use devices be shared with covered entities, this information then becomes subject to HIPAA regulations.
Medical device manufacturers could be considered business associates in some situations. However, to mitigate any risk of HIPAA violations, it’s best to design all devices to be HIPAA compliant regardless of the device’s expected use.
What HIPAA means for medical device manufacturers
HIPAA compliance requires the meticulous design and implementation of security for medical devices to ensure that only authorized parties have access to an individual’s health data. In today’s digital world, cybersecurity and data privacy concerns make device security all the more important. While HIPAA compliance can be difficult for medical device manufacturers, especially since manufacturers must also satisfy Food and Drug Administration (FDA) standards for their devices and ISO 13485 standards for their processes (should the manufacturer be ISO 13485 certified ), it doesn’t have to be. Here are 4 steps that can be taken to ensure that devices are HIPAA compliant:
1. Secure devices with encryption
Manufacturers should encrypt PHI and e-PHI data on medical devices to prevent cybercriminals from accessing them. Hackers typically break through a network’s security via its weakest link which, more often than not, ends up being unsecured devices. They use stolen data for crimes like identity theft and fraud. By encrypting both incoming and outgoing data, medical device manufacturers can be confident that their security measures will be HIPAA-compliant.
2. Implement biometric security
Advanced security measures like biometrics help ensure that only the patient and authorized parties view their PHI. By incorporating fingerprint, iris, or facial recognition scanners in their medical devices, manufacturers add an extra layer of protection from potential criminals. Not only does this protect the patient, healthcare provider, and manufacturer from potential HIPAA violations, but it also helps improve the accuracy of record keeping.
3. Apply administrative safeguards to devices
Including administrative safeguards on medical devices, such as password protection or personal identification numbers (PINs) to be able to access devices is another way to protect them from unauthorized access. These safeguards may also be useful, such as automatic censoring of unneeded, sensitive data like names, addresses, test results, etc. when data is exchanged between two parties.
4. Sign a business associate agreement
Another way to ensure HIPAA compliance is for manufacturers to sign a “business associate agreement” with whatever covered entities it works with. Signing this agreement shows that a manufacturer understands and follows HIPAA privacy and security rules. These documents showcase how a manufacturer plans to protect, use, and disclose PHI. Consequently, manufacturers must stand by this agreement for each device that leaves their doors, otherwise, they can face penalties. Through this, business associate agreements help ensure HIPAA compliance in the long term.
Protect yourself from HIPAA violations
As the world becomes increasingly reliant on digitally delivered medical data, the cybersecurity of medical devices becomes ever more important. It’s up to you, the manufacturer, to ensure that as more technologically advanced devices are released to the market, these devices are compliant with HIPAA. Here at ACHB, regulatory compliance remains at the forefront of our operations. Contact an ACHB sales representative today to discuss your medical device manufacturing needs.