These laws and regulations are put into place to protect sensitive health information that shouldn’t get leaked. Failing to comply with the following regulations can lead to fines or criminal prosecution. Here are the most critical healthcare compliance laws.
Health Insurance Portability and Accountability Act (HIPAA)
Originally signed into effect in 1996, HIPAA aims to protect patients’ sensitive health information. HIPAA compliance is mandatory for all healthcare organizations and their business associates. While HIPAA is specific to the United States, most countries have a similar equivalent.
HIPAA is made up of three rules:
The Privacy Rule
The Privacy Rule limits the disclosure of an individual’s health data. This information gets classified as protected health information (PHI), which is protected under HIPAA. This typically includes data secured on electronic information systems, which are vulnerable to cyberthreats.
The Security Rule
The Security Rule mandates that HIPAA-covered entities complete a risk assessment. A risk assessment is conducted by a compliance officer and is intended to find security risks within your company.
The Breach Notification Rule
The Breach Notification Rule demands that HIPAA-covered entities notify the right channels when they’ve had a breach of private health information.
Quality System Regulation (QSR)
Quality System Regulation is an FDA-led initiative to increase the cybersecurity of medical devices. This was partially created because of ransomware attacks that shut down medical facility networks. These attacks could cause medical devices like pacemakers, drug infusion pumps, or insulin pumps to stop functioning and harm patients.
QSR standards require medical device manufacturers to incorporate data encryption or authentication on their devices. While these standards mostly apply to medical device manufacturers, the FDA states that healthcare establishments share the responsibility. Penalties for QSR non-compliance include fines of up to $500,000 and criminal prosecution.