• There are no suggestions because the search field is empty.

Case Study: Safe Health

Posted by Sierra Labs on Oct 14, 2020 8:47:00 AM

How Sierra Labs helped Safe Health win enterprise customers with HITRUST and SOC2 Compliance.

Hero-049-1

Background

Recently, the Centers for Disease Control and Prevention (CDC) has urged organizations who are resuming their operations to conduct daily health checks on employees due to the prevalence of COVID-19. Now more than ever, it is critical for employers to have the ability to provide convenient screening options and dedicated on-site or at-home testing for their employees. 

Safe Health Systems, Inc. is a start-up diagnostics company developing a solution that enables employers to conduct regular health check-ups for their employees. Their symptom checking platform will support the safe transition from remote to on-site work.

Challenges for Safe Health

In order for a startup, like Safe Health, to deliver a widespread solution, they must address a number of challenges regarding their product development and data security. These obstacles are:1037

  1. Starting From Scratch:
     
    • Like any startup developing a solution in this space, Safe Health lacked a quality system and this can present obstacles for product development. Without a quality system, it is challenging to meet regulatory standards when working in a rapidly changing and highly dynamic environment.

  2. Remote Work:
     
    • Working remotely has been another challenge for Safe Health. Working as a distributed company without proper guidance can backtrack overall product development. Safe Health needed guided expertise from an external quality team that can implement a coordinated strategy into their development processes.

  3. No QA/RA Team:
     
    • To ensure development processes are maintaining high-level standards, Safe Health looked to obtain HITRUST and SOC2 Certifications. Without a quality team, Safe Health hit roadblocks in finding proper solutions to mitigate risks when handling and maintaining sensitive data. They also needed assistance with strategy and gathering the right documentation for the certification process.

  4. Audits
     
    • Safe Health’s goal was to partner with several enterprise-level clients, but with large enterprises come lengthy audits to ensure all bases are covered. These enterprise-level audits can be daunting, require a lot of manpower, and effectively slow down production. Without a QA/RA team, these factors can be intensified greatly. Safe Health needed a team to help handle all of these audits to ensure they could keep landing these enterprise customers.

Solutions

Sierra Labs has been actively working with Safe Health to tackle each of the 4 obstacles and ease their regulatory journey to HITRUST and SOC2 Certification.

  1. Starting From Scratch:
     
    • Sierra Labs played a key role in building Safe Health’s organizational chart, which created functional segregations and led to more structure and clarity in their operations. Based on their maturity stage, Sierra Labs clearly defined their policies to help engage with their enterprise clients handling audits and responding to their observations.

  2. Remote Work
     
    • Sierra Labs acts as Safe Health’s quality team to ease the difficulties of having an entirely remote staff. Sierra Labs manages their security efforts and has helped stand up their Quality Management System (QMS), unifying the distanced work and thus improving work efficiency. Our resources serve as their external and consolidated team that manages assessments, audits, and certifications.

  3. No QA/RA Team:
     
    • Sierra Labs is acting as Safe Health’s QA/RA team, ensuring they obtain their desired certifications and leading their interactions with regulatory bodies. Sierra Labs is providing firsthand knowledge with both HITRUST and SOC2 Certifications to develop a unique strategy tailored toward their security objectives. Our team has established a clear timeline to help establish efficient workflows and documentation to prepare for certification requirements.

  4. Audits:
     
    • Sierra Labs eases the regulatory stress for Safe Health by handling their enterprise audits. This drastically reduces their time and effort spent on compliance, allowing them to focus more of their attention on product development, quality production, and innovation of their COVID-19 solutions. This has enabled them to take on more and more of these enterprise-level customers and ultimately scale their business.

Learn more about HITRUST and SOC2 Certification requirements as they pertain to your medical device!

Results

HITRUST CSF has become the most popular and widely adopted security framework in the U.S. for the healthcare industry due to its data security measures. With Sierra Labs, Safe Health was able to have a full breakdown of the available options for achieving HITRUST Certification. By conducting a holistic evaluation of the organization’s current security measures, Sierra Labs was able to provide feedback and act as their compliance team to ensure their company is taking the necessary steps to achieve HITRUST certification.

Serving as a complement to HITRUST, SOC2 Certification addresses risk concerns through a third-party audit that primarily focuses on non-financial reporting controls, policies, and procedures. From the get-go, Safe Health Systems experienced guidance from Sierra Labs in demonstrating the company can protect and handle personal information security. Sierra Labs helped build and implement standards for securing data following the Trust Services Criteria (TSC) in order to be SOC2 audit-ready. 

Client References

Secure Compliance With Less Stress

Are you a startup in the Healthcare or Life Science space looking to achieve any of the following?:

  • Create a Solid Quality Strategy / Plan
  • Obtain Certifications or Complete Submissions
  • Pass Audits with Flying Colors
  • Land Enterprise Customers
  • Scale Your Business

Our combined expertise and experience can help with all of the above! We will act as your Quality and Compliance function and you will no longer need to stress over the compliance aspect of your business, leaving you with more time to focus on your innovations and product development.

Sierra Services will get your team on track to achieving your regulatory goals while helping you avoid any risks that can compromise your solution to market. We will guide you through every step of the way to ensure your team feels safe and confident for inspections and assessments.

Need Help Achieving Your Regulatory Goals?

Click Here for a Free Consultation!

Sierra Services

Ask us anything!

Topics: SaMD, Data Security, Medical Device Company, Data Privacy, COVID-19 Solution, Data Requirements, SaMD Development, Software Requirement Specification, HIPAA, Personal Health Information, Health Data, PHI, eHealth, SOC 2, HITRUST, SOC, HITRUST CSF, Client Reference, Case Study

Recent Posts

Topics

See all

Subscribe Here