What is the cost of a HIPAA/PIPEDA compliance software audit?

October 05, 2022 / Time to read: 3 minutes
What is the cost of a HIPAA/PIPEDA compliance software audit?
In the world of patient data security, Canadian healthcare organizations are obliged to meet HIPAA and PIPEDA requirements. And you wouldn’t like to violate them, considering that you may be charged up to $100,000 per incident.

[vc_row][vc_column][vc_column_text]At the same time, neglecting patient data privacy requirements undermines your reputation in the highly competitive market: according to recent American Medical Association (AMA) findings, nine out of ten patients believe they have a right to privacy, while almost two-thirds are concerned about whether their health data is properly protected.

Both HIPAA and PIPEDA enforce data privacy standards that must be followed. While HIPAA focuses specifically on health information, PIPEDA (or the Canadian HIPAA) was developed to safeguard all sorts of personal data, including health-related information.

To avoid costly fines and reputational losses, healthcare organizations conduct HIPAA and PIPEDA compliance software audits. In this article, we explain what points to mind and how much you may pay for it.

Checklist: Is Your Healthcare App or Website HIPAA/PIPEDA Compliant?

If you don’t use PIPEDA or HIPAA compliance audit software, you may conduct a manual audit to ensure your healthcare application or website doesn’t violate patient data privacy requirements.

PIPEDA Compliance Requirements

  • User consent for data collection. This includes such personal identification and orientation details as ID numbers, names, demographics, and ethnicities, as well as social statuses, evaluation reports, medical reports, etc. Patients should agree to share the information before you collect, use, or disclose it.
  • A product or service is provided even if a user rejects data collection. In other words, you can’t prohibit a patient from accessing your website data or making an appointment even if they refused to share private data.
  • Fair and lawful data collection. Some possible violations include but aren’t limited to: the collected information is disclosed not for the purpose it was collected for (i.e., it was resold or published on an open-source platform), or discrimination based on an ethnic, demographic, or other factor takes place.
  • Transparent corporate data collection policies. You should collect only vital information and inform a patient on how the data will be used. Furthermore, you need to enforce transparent corporate data collection and usage policies across your medical organization.
  • Constant data access. Patients have a right to access their data at any time and to request corrections if needed.

HIPAA Compliance Requirements

  • HIPAA-related documentation. You must develop ten obligatory HIPAA-related documents that cover risk analysis and risk management, sanctions applied to staff in case of violation, security responsibilities and reminders, response and reporting policies, emergency mode, Business Associate Agreements (BAA), and a HIPAA privacy policy for BAA, as well as contingency plans. You may also need to create uses and disclosure of PHI and Security awareness and training documents.
  • Protected physical environment. Devices and medical equipment that record, receive, or transmit PHI must have regulated access (even in case of an emergency), have theft prevention policies applied, and be regularly maintained and modified.
  • Ensure software security. This includes such measures as limited session time to prevent unauthorized access, strict access control, user authentication, activity tracking, data encryption that meets NIST requirements, PHI data back-up stored on a third-party server, secure data sharing, transfer, and correspondence.

How Much Does HIPAA/PIPEDA Compliance Audit Cost?

PIPEDA/HIPAA audits and your software are two additional expenses that must be added to your budget. Auditors typically charge based on an hourly rate, so to estimate the approximate cost of a HIPAA/PIPEDA compliance audit, you first need to calculate the scope of work required.

If outsourcing or hiring an auditor isn’t an option, you can:

  • Use automated software compliance audit. The cost may range from $25 per month to approximately $166 per month ($2,000 per year), according to the data published by Capterra.
  • Request on-site audit. Agencies may charge $4,000-12,000 per audit for a small business, while medium and large businesses may pay a minimum of $50,000.

While the latter option is costlier, you get not only a comprehensive HIPAA/PIPEDA software compliance audit but also risk management, vulnerabilities scans, penetration testing, the development of corporate policies, employee training, and more.

How to Ensure HIPAA/PIPEDA Software Compliance

  • Hire a full-time compliance officer to set up data privacy policies, regularly review them, and ensure they are properly implemented
  • Conduct a regular compliance audit to prevent violations and keep track of data privacy changes that should be applied in a certain timeframe.
  • Educate your employees. Both HIPAA and PIPEDA imply developing corporate data privacy policies, which become useless if your staff doesn’t follow them.


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