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Mapping HealthTech Compliance

Finding Your Best Path to Comprehensive Compliance

This curated collection of content will help you build a roadmap to pursue the best frameworks for your company and know when to leverage them. Plus, learn how to accomplish more of your compliance goals from a single assessment.

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00. Your compliance roadmap

Compliance for HealthTech

Are you "compliant enough"? Startups to mature HealthTech companies (and everywhere in between) can struggle to answer that question. 

With so many frameworks to choose from, you must get your compliance program right from Day 1. With the average healthcare data breach costing over $10 million1, mistakes can be costly.

The following content will guide your HealthTech company towards its ideal compliance posture and set you up to build and execute a strategic compliance roadmap for your company. 

Read on for more helpful information, or contact one of our experts if you're ready to get started! 

Speak to an expert

Achieving compliance across multiple frameworks enhances your company's trustworthiness and credibility among customers, partners, and regulatory bodies in the market and sales process.

Zach Rutz | Manager, HITRUST Assurance

01. Understand your frameworks

Which frameworks are best for your organization?

When it comes to healthcare compliance for small and mid-sized companies, the most impactful certifications and/or attestations to start will be SOC 2, HIPAA, and HITRUST (or a combination of the three.)

Because HealthTech companies handle vast amounts of highly sensitive data, they face more potential risks than other industries.  Healthcare organizations are constantly hit with cyberattacks that leak this sensitive patient information and cost companies thousands—if not millions—of dollars and put their reputations on the line.

This free guide breaks down SOC 2, HIPAA, and HITRUST and how they can augment your HealthTech compliance program and protect your organization from hefty fines and reputational damage.

Get the guide
Comparing SOC 2, HIPAA, and HITRUST

Find your framework(s)

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Not sure where to start?

Build your custom roadmap

Thoropass can build a custom roadmap to help your telehealth, value-based care, or population health company achieve multiple compliance goals with a single audit.

Talk to an expert

Director of Compliance and CISO, Jay Trinckes, on best practices to maintain continuous compliance. 

02. SOC 2 for HealthTech

Achieving and maintaining SOC 2

Embarking on the journey to achieving SOC 2 can be challenging—then monitoring and maintaining it is another hurdle entirely.

HealthTech companies deal with the added challenge of navigating all of this within a highly regulated industry, from managing a complex procurement process to having to prove your compliance posture to partners with extensive third-party risk assessments.

We know SOC 2 isn’t a one-size-fits-all approach, and businesses implement and maintain SOC 2 in various ways. As a first step, it’s important to ensure that all your boxes are checked. As a next step, you’ll need to understand how to customize your SOC 2 journey to ensure your HealthTech company maintains continuous compliance.

Use your interactive SOC 2 checklist

 

SOC 2 SUCCESS STORY

SOC 2 helps drive shortened sales cycles in a highly regulated space

AcuityMD is in the MedTech space, so if anyone understands navigating enterprise procurement in a highly regulated space, it’s their CEO, Michael Monovoukas. By achieving SOC 2, they ensured they didn’t leave any deals on the table.

03. HIPAA compliance

HIPAA compliance for HealthTech

You’re likely already aware that HIPAA, or the Health Insurance Portability and Accountability Act, protects patient privacy and keeps patient data safe. HIPAA sets national security and privacy standards for protected health information (PHI) and is enforced by the Office for Civil Rights (OCR) of the U.S. Department of Health.

You may not know how HIPAA maps to other frameworks like SOC 2 and HITRUST. There is significant overlap between HIPAA rules, SOC 2 Trust Service Criteria, and HITRUST CSF controls. HealthTech organizations can take advantage of this overlap by satisfying more than one certification or attestation with a single audit2. For example, if you pursue SOC 2, you'll be 80-90% of the way to achieving your HITRUST e1 certification as well! 

 

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Consolidating audits for multiple frameworks and certifications into one process is more efficient and cost-effective. It reduces the need for multiple audit cycles, which can be time-consuming, disruptive, and expensive

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Zach Rutz

Manager, HITRUST Assurance

HIPAA Privacy and Security Rules

HIPAA Privacy and Security Rule is covered under the Administration Simplification provision. It's broken up into three different rules: the Security Rule, the Privacy Rule, and the Breach Notification Rule.

Guide to HIPAA compliance

Understand HIPAA compliance for your business

Depending on the age and stage of your business, you may need HIPAA Security, HIPAA Privacy, or both. Download the guide to understand what your company must follow (and what happens if you don’t.)

Download the guide
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04. HITRUST

HITRUST vs. HIPAA

While HITRUST is not a government regulation, it’s based on many regulatory and industry standards, including HIPAA. Obtaining HITRUST certification requires a more comprehensive set of requirements and a more thorough evaluation process than HIPAA—that’s why many refer to it as the ‘gold standard’ in healthcare tech compliance5.

Whether or not you need HIPAA, HITRUST, or a combination of the two will depend on the type of data you process and the type of vendors and customers you work with.

As mentioned, HIPAA is a federal regulation setting standards for protecting protected health information and is essentially self-reported. Whereas HITRUST is a voluntary third-party certification you can obtain to demonstrate your organization’s commitment to protecting sensitive information and, therefore, can carry more weight if you do business with health plans or hospital systems.

See how HITRUST and HIPAA compare by downloading the PDF.

Download the PDF
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HITRUST eBook

HITRUST as a business differentiator

HITRUST is becoming the most globally recognized way for HealthTech companies to show they proactively manage security risks and comply with industry standards and leading practices for information security. In many cases, it's a requirement to do business.

Download this free guide for a deep dive on how your HealthTech company can leverage HITRUST to stay ahead of the curve.

Get the FREE eBook

The HITRUST Certification includes three types of assessment, each with unique requirements and timelines. The following explains each one to help you decide how to get started.

The ability to demonstrate compliance across multiple, trusted frameworks has become table stakes for effective entry and growth within the HealthTech industry.

Zach Rutz | Manager, HITRUST assurance

05. Get your custom roadmap

Thoropass is the most experienced and qualified partner for any HealthTech company pursuing SOC 2, HIPAA, HITRUST (and more!)

With our in-house auditors, you’ll be able to achieve multiple frameworks with a single audit—with no surprises along the way.

"If my previous audits were offered to me for free—I’d still pay for Thoropass."
Josh Horowitz
Josh Horowitz CTO, Stylo
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Resources

More resources to help you navigate your compliance journey

FREE QUIZ Which HITRUST assessment is right for your business?
 Find out which HTIRUST Assessment is right for your business with this free assessment.
Take the quiz
Blog Post HITRUST custom controls and expert guidance

Learn why working with an approved assessor is critical while navigating HITRUST Certification.

Learn more
Guide How SOC 2 can unlock business growth

Learn how to leverage your SOC 2 report as a business accelerator.

Get the guide