Navigating SOC 2 Compliance in Digital Health: What You Need to Know

SOC 2 compliance is a critical component of any digital health organization. When healthcare professionals, patients and vendors all have their data in one place, it’s important that the security standards are high enough to protect against any breaches. A SOC 2 audit will help an organization prove that they’re doing everything they can to protect personal information, which is especially important for digital health providers who handle sensitive patient data.

SOC2 compliance in digital health

In this guide, we’ll discuss why you need to comply with SOC 2 regulations and how easy it is to get started with certification from the start-up stage through acquisition by a larger vendor (or even if you’re not looking at buying anything just yet!).

SOC 2 Introduction

SOC 2 for Digital Health is a set of standards for service organizations. It’s the most widely used service organization control framework in the world and helps customers understand how an organization manages data, software, and technology assets.

SOC 2 was originally developed by The Committee on Service Assessment (COSA) in 1999 as an extension of their Sarbanes-Oxley compliance efforts. In 2002, COSA created the Service Organization Control (SOC) Framework to provide guidance to companies on how they could report on their internal controls over information security or operational risk management processes. Since then it has evolved into what we know today: a set of principles designed to help organizations manage their own internal controls related to information security and operational risk management processes through independent assessment by qualified professionals

What is SOC 2?

SOC 2 is a set of standards for the certification of service organizations. It was created by the American National Standards Institute (ANSI) in 2002, and it’s used by many companies in all industries to prove that they’re adhering to best practices when it comes to security and privacy. While SOC 1 refers specifically to financial services, SOC 2 applies more broadly across industries–including healthcare.

Why You Need to Comply

The most important reason to comply with SOC 2 is that it establishes trust with your customers. Patients want to know that their data is secure and being used responsibly, so you need to prove that you’re doing it right.

If your company has a reputation for doing things in an ethical manner, then patients will feel more comfortable sharing personal information with you–and this can lead to increased revenue opportunities down the road. For example, if a patient doesn’t have access to his own medical records because they’re locked away somewhere inaccessible by anyone but him (like in an EHR), he might decide not even bother getting treatment at all!

That’s why compliance with standards like SOC 2 helps establish trust between healthcare providers and patients: by complying with these standards and demonstrating how they protect sensitive information while still allowing people access when necessary (such as allowing doctors access).

How to Comply

SOC 2 compliance is a process, not a product.

It can be done by an auditor or by self-assessment.

It’s not just about security–it’s also about protecting your data.

SOC 2 compliance is key in digital health

In today’s digital health space, SOC 2 compliance is a good step toward establishing trust with consumers, investors and partners. It shows that you’re committed to providing them with secure data protection practices that meet industry standards.

It also demonstrates your commitment to meeting those standards through ongoing monitoring, testing and reporting of your systems’ effectiveness in protecting sensitive information.

SOC 2 Application to Digital Health

SOC 2 is a standard that applies to any organization that collects, processes and stores data. Because SOC 2 is directly applicable to digital health organizations, it’s important for you to understand how your company can leverage this certification as part of their overall compliance strategy.

To ensure that you’re on track with SOC 2 compliance requirements and best practices for collecting personal information from your customers or patients–and in turn building trust with them–it’s critical for you as a CIO or CISO (Chief Information Security Officer) within an organization seeking SOC 2 certification:

  • Understand what exactly constitutes “personal information” under the law;
  • Understand where personal data resides within your company’s infrastructure;
  • Develop internal policies around storing and protecting sensitive health information;

For example: Do we have backups? How quickly can we recover lost data? Who has access rights?

Data science in healthcare

SOC 2 Compliance for Certificates of Recognition (CoR)

SOC 2 is a good step in establishing trust with consumers, and it’s also a good way to demonstrate that your organization has controls in place for protecting data. The process of becoming SOC 2 compliant can be lengthy, but the end result is worth it: you’ll get a Certificate of Recognition (CoR) from the AICPA and an attestation report that details how well your company protects customer information and how much control it has over its operations.

The first thing to know about SOC 2 compliance is that there are two versions: SOC 2 Type 1 or Type 2. Type 1 covers service organizations while Type 2 covers software development firms; both types must adhere to similar principles but have different requirements based on their respective industries.

SAS 70 Type II Certification

SAS 70 Type II Certification is a standard for financial services and can help build trust with consumers. However, it is not required for SOC 2 compliance.

SOC 3 Compliance for CoR

SOC 3 compliance is a good first step for establishing trust with consumers. It’s also an important next step after SOC 2 and SAS 70 Type II, which are required by many healthcare organizations.

SOC 3 focuses on privacy and security practices, including the following:

  • Data collection, storage and use;
  • Access controls;
  • Physical safeguards;
  • Incident response capabilities.

SOC 2 is a good step in establishing trust with consumers.

SOC 2 is a good step in establishing trust with consumers. For example, if you’re a digital health company and you have been working hard to build trust with your patients, then SOC 2 compliance can help solidify that trust.

SOC 2 compliance also helps demonstrate your ability to be HIPAA compliant–a big deal when it comes to protecting patient privacy and data security. In fact, this is why many healthcare organizations choose SOC 2 audits: they want an independent third party’s validation that their systems are secure and trustworthy before receiving government funding or participating in public-private partnerships (PPPs).

Finally, it’s important for consumers who are looking for reliable healthcare providers online because they know that SOC 2 certification indicates that the organization has undergone rigorous testing by an independent auditor who will report back on any issues found during his/her review process


SOC 2 compliance is a good step to establish trust with consumers. It shows that you are willing to be transparent about the security of your product, and it gives customers confidence that their data will be protected from hackers or other malicious actors.

SOC 2 compliance can also help build credibility by demonstrating that your company has taken steps toward protecting sensitive information such as health records.


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