May 23, 2023

HIPAA Basics: A Guide for Startups

The Health Insurance Portability and Accountability Act, passed in 1996, was originally created to protect sensitive healthcare data from breaches, exposure, and misuse on the part of companies entrusted with that data. If your business manages or handles any protected health information—even if you aren’t an insurance provider—the laws of this act apply to you.

HIPAA compliance may not be a new concept for large, established firms that have been managing health data for years. But far too often, fledgling startups place HIPAA at a low position on their list of priorities, and as a result, they find themselves scrambling to stay ahead of the scrutiny of potential clients.

What is HIPAA and why does it matter?

HIPAA can be broken down into three central components: 1) the Privacy Rule, which protects individual health information, 2) The Security Rule, which sets national standards for data security, and 3) the Breach Notification Rule, which requires companies to report any breach of protected information. Protected information can include health records, social security numbers, contact information, clinical notes and insurance details.

How to determine if HIPAA rules apply to your company

The law identifies two lists of entities that need to stay compliant: Covered entities and business associates. Covered entities include doctors, hospitals, insurers, self-insured employers and companies that process and handle claims. “Business associates” include all those who handle data on behalf of these covered entities. Most startups that are caught off guard by HIPAA compliance issues fall into the “business associates” category; if you haven’t investigated these issues or assume HIPAA rules don’t apply to you, take a closer look.

Early stage development and early financing rounds represent the best time to secure all issues and to-dos related to regulatory compliance, and companies that handle and manage sensitive data would be wise not to put off this task. Securing data from the ground up will help businesses build with compliance in mind, and will help them avoid the struggle of paying hefty fines after being reported to the government.

Bear in mind that HIPAA accountability transfers between connected companies, so a violation or breach at a startup “business associate” will also represent a breach for the company’s customers. Large clients (like hospitals and insurers) may hesitate to associate themselves with startups that haven’t rigorously addressed all compliance issues well in advance of any partnership. So establishing compliance won’t just keep a company out of trouble; it can also open the door to larger contracts.


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Frequently Asked
Questions

What type of compliance standard can you help with?

We help our clients based on their needs. The majority of our contracts involve SOC-2, HIPAA, and most recently GDPR. Feel free to ask us if we can help with your particular case. If we aren't able to, we can most likely recommend you to someone who can.

How long does a SOC 2 engagement usually take?

We move as fast as our clients are able to make progress. Our fastest client to date got their SOC-2 Type I four months after signing our engagement letter. That record is up for grab if you are up for it.

In our experience however, it takes 6-9 months to achieve a SOC-2 Type I,  and 3-6 additional months to obtain a SOC-2 Type II report.

Which standard do you follow for your security policies?

All of our security policies follow the ISO-27001 standard. The Confidentiality, Integrity, and Availability standards cover the range of standards we like to work with for SOC 2.

Why do we have to become SOC 2 compliant if we are relying on AWS which is already compliant?

SOC 2 stands for Service Organization Control, meaning your clients are interested in understanding your controls, not your hosting provider’s control. As part of your vendor assessment we recommend reviewing AWS’ SOC 2 report, but relying on their report is not enough to become SOC 2 compliant.

Who is behind SOC 2?

The American Institute of CPAs. The AICPA is an established and respected organization that provides two forms of audits to companies that demonstrate evidence of a secure data-protection infrastructure. A Type I is a point in time audit that addresses the company’s description of its system, the suitability of the system’s design, and the effectiveness of its internal data controls. A Type II report happens over a period of time and emphasizes design and also focuses on the validity of the company’s controls.

Are SOC 2 reports a legal obligation?

No, but most enterprise level organizations that engage with sensitive data (again, almost all of them) have an obligation to their stakeholders to prove due diligence regarding data security, which means they’ll want to vet their service providers using this tool. SOC 2 can help these prospective service providers set themselves apart from the competition. Just as important, a SOC 2 report represents a meaningful and respected signifier of trust.

What can happen to a company without a SOC 2 report?

A lack of a SOC 2 report won’t result in legal problems, but it can and will limit outside assessments of the company’s commitment to data security. When large-scale clients look for providers, or large-scale backers look for a likely return on their investment, they don’t want concerns about security to stand in the way. Trust is a chain made of links that have each been put the test and have proven their ability to withstand pressure and scrutiny. Company leaders are wise to let SOC 2 auditors apply this pressure so their clients and backers don’t have to.

When is it too late for a SOC 2 audit?

Never. Even companies that have been in business for years but have never obtained a SOC 2 report can—and should—take steps in this direction now. Being compliant with SOC 2 can open the door to a broader base of more significant clients and larger contract opportunities. That being said, startups in the threshold of the marketplace, and new business owners who hope for an eventual public offering, should obtain a SOC 2 report during the development and financing process. By the time the company approaches Series B and C fundraising rounds, a report should be in hand.

How complicated is the auditing process?

The auditing process can be easy, or complicated depending on your level of preparation.

Preparing for the audit can take some time, attention, and the guidance of reliable data security experts. Don’t leave any part of this process to chance. Approach SOC 2 compliance one step at a time, and start by contacting a consulting firm with track record of experience in your area of the marketplace.