Achieving HIPAA Compliance & Ensuring Security on AWS for a Medical Device Manufacturer 

Client Background

A leading manufacturer of medical devices for blood pressure and pain management, this company also offers comprehensive healthcare solutions to support doctors, hospitals, patients, and healthcare support staff in building a robust healthcare infrastructure.

Project Overview

The project involved achieving Health Insurance Portability and Accountability Act (HIPAA) compliance and ensuring security on AWS for a leading medical device manufacturer. We implemented robust security measures, including access controls and encryption, while providing a HIPAA-compliant Business Associate Agreement. Additionally, we established a disaster recovery plan and implemented a comprehensive security incident management framework. Our efforts ensured the secure handling of patient data and compliance with HIPAA regulations.

Business Requirements

The client wanted a robust platform on AWS that could ensure safe handling & processing of huge volumes of data in compliance with HIPAA requirements. The platform serves a wide user base, including millions of mobile app users globally and numerous hospitals across North America (NA) that rely on remote patient monitoring to manage thousands of patients.

Challenges

Huge Volume of Sensitive Data
The client manages a significant quantity of sensitive data from mobile app users and remote patient monitoring services offered by hospitals throughout North America. The highly confidential Personal Health Information (PHI) and Personally Identifiable Information (PII) of patients posed a challenge as there was no scope of a miss in security.

Thorough HIPAA Compliance
Due to the sensitive nature of the PHI and PII of patients, the client’s cloud infrastructure must fully comply with HIPAA regulations and strictly follow all security guidelines and best practices. The challenge is particularly steep when integrating IT solutions with existing hardware systems.

Fully Secure Environment
The client sought a team of experts to assist them in establishing and maintaining a secure Continuous Integration/Continuous Deployment (CI/CD) implementation on AWS. The objective was to create an environment that fully complies with security guidelines, including infrastructure vulnerability scans.

Solution

Security Measures & Incident Management Implementation 
Our security team successfully addressed security gaps and enhanced the client’s security posture. This included implementing missing security processes, policies, and operational procedures, aiming to improve the client’s security maturity ranking across multiple assessment measures. We also developed a comprehensive cloud security policy, improved supplier security risk management, implemented static security code scans, established a security incident management framework, collaborated on a cloud-native security monitoring solution, and set up a 24/7 Network Operations Team.

Ensuring Patient Data Security & HIPAA Specific Compliance 
We worked closely with the client to ensure the secure handling of sensitive patient data by implementing HIPAA-specific compliance measures on the AWS cloud platform. Our security team meticulously designed and configured the infrastructure to adhere to the stringent requirements outlined by HIPAA regulations. This involved implementing robust security controls, encrypting data at rest and in transit, and establishing strict access controls and audit trails. By leveraging AWS services such as AWS Identity and Access Management (IAM), AWS CloudTrail, and AWS Key Management Service (KMS), the client’s cloud environment was fortified to meet the rigorous standards for protecting patient privacy and maintaining data integrity. Also, AWS provides a HIPAA-compliant Business Associate Agreement (BAA) for its healthcare clients, eliminating the need for the client to engage multiple vendors to obtain BAAs. By choosing to work with us on AWS, the client benefited from this streamlined approach, which significantly simplified the compliance process.

Implementing Robust Disaster Recovery and Business Continuity Strategies 
Our team strategized and executed a comprehensive disaster recovery plan tailored to meet the client’s specific business needs, including Recovery Point Objective (RPO) and Recovery Time Objective (RTO) requirements for their services. Through periodic “Dry Runs,” the effectiveness and relevance of the disaster recovery strategy were continuously evaluated and updated, ensuring its reliability and alignment with the client’s evolving needs.

Results

Comprehensive HIPAA Compliance
We streamlined the compliance process for our healthcare client by offering a HIPAA-compliant Business Associate Agreement (BAA), eliminating the need for multiple agreements. We also took all the necessary actions to ensure thorough compliance with HIPAA. In addition to it, we successfully implemented a robust disaster recovery plan, ensuring the client’s business continuity and resilience in the face of potential disruptions.

Strengthened Infrastructure Security
We also established a robust security incident management framework, enabling efficient response to security incidents. Collaborating with stakeholders, we implemented a cloud-native security monitoring solution, facilitating better threat analysis and ensuring adherence to security requirements. To ensure round-the-clock monitoring and response, we established a dedicated 24/7 Network Operations Team. Additionally, we created cloud incident response runbooks with conditional steps, enabling swift assessment, investigation, and containment of incidents. These comprehensive measures significantly strengthened the overall security posture, ensuring secure and trustworthy software systems and proactive incident management.

Patient Data Security
By implementing industry best practices and leveraging cutting-edge technologies, we created a secure environment that instilled confidence in the client’s ability to manage and process sensitive patient data with the highest level of protection.

Deepesh Goel

Seasoned Technology leader with 25 years of diverse experience in delivering software products and solutions across connected healthcare, retail, and finance verticals serving large enterprises as well as nimble startups globally.