Startups in Healthcare Targeting the U.S.: Take Action Now to Become HIPAA Compliant

Any startup that collaborates with a healthcare organization in the United States must demonstrate compliance with HIPAA, the Health Insurance Portability and Accountability Act. This includes ‘business associates’ of healthcare settings, including software development companies who develop products or provide services to the healthcare providers.

Established in 1996, HIPAA mandates that anyone who handles protected health information (PHI) must safeguard the privacy and security of this data. Properly demonstrating HIPAA compliance can benefit the entire organization.

Under HIPAA, protected health information encompasses any health data that can be linked to an individual. This includes health information such as diagnoses, treatment details, test results, and prescriptions, along with identifying information about the patient, such as their name, location, contact details, and payment information.

Ignoring these regulations can be very expensive.

Penalty Structure for HIPAA Violations

Tier 1

Penalty Range: $141 – $71,162 Per Violation
Maximum Penalty: $2,134,831 Per Year
Criteria:
Unaware of the HIPAA violation and by exercising reasonable due diligence would not have known HIPAA Rules had been violated.

Tier 2

Penalty Range: $1,424 – $71,162 Per Violation
Maximum Penalty: $2,134,831 Per Year
Criteria:
Reasonable cause that the covered entity knew about or should have known about the violation by exercising reasonable due diligence.

Tier 3

Penalty Range: $14,232 – $71,162 Per Violation
Maximum Penalty: $2,134,831 Per Year
Criteria:
Willful neglect of HIPAA Rules with the violation corrected within 30 days of discovery.

Tier 4

Penalty Range: $71,162 – $2,134,831 Per Violation
Maximum Penalty: $2,134,831 Per Year
Criteria:
Willful neglect of HIPAA Rules and no effort made to correct the violation within 30 days of discovery.
Startups: Don’t Ignore Compliance – Act Now*

As a startup, it’s easy to focus solely on growth and overlook compliance due to limited time and resources. However, neglecting compliance can lead to serious legal consequences, including fines and even shutdown. Every industry has its regulations, and adhering to them is vital for building consumer trust and maintaining a good reputation.

Compliance also offers an opportunity to streamline processes and enhance operational efficiency. For startups in technology and innovation, compliance with privacy and cybersecurity regulations is crucial. Non-compliance can result in data breaches and legal issues.

If you operate globally, you must also comply with a complex web of international regulations, as these rules can frequently change. Recognizing compliance as a proactive measure demonstrates a commitment to ethical practices and safeguards your startup’s growth and reputation.

Seeking early guidance is essential in today’s landscape. Our mission is to help businesses navigate regulatory complexities and turn their visions into reality. Don’t let misconceptions about compliance hold you back; embrace accessible solutions that will drive your entrepreneurial success.