HIPAA Compliance Roadmap for Eye Diagnostics iOS Apps

About Our Client

The Client is a startup created by a US ophthalmology clinic. The team of professionals from the fields of optometry, ophthalmology, neurology, and neuroophthalmology have joined forces to develop two iOS apps for eye diagnostics: one for patients and one for healthcare providers. The apps aim to enhance eye healthcare by allowing diagnostics of various eye conditions using iris and retina image analysis.

Need to Clarify HIPAA Requirements for the Development of Eye Diagnostics Apps

Aware of the need to ensure HIPAA compliance for the planned apps, the Client sought a software consulting company proficient in HIPAA regulations. As the Client was considering offshore development, their main concern was understanding HIPAA requirements for the outsourced development company, including the need for a Business Associate Agreement. Trusting ScienceSoft’s 19 years of experience in healthcare IT and 20+ years in cybersecurity, the Client turned to us for HIPAA consulting.

HIPAA Consulting to Build Secure Eye Diagnostics Apps

ScienceSoft assigned a compliance officer with over 20 years of IT consulting experience to the project. Over the course of three months, he provided 40 hours of HIPAA compliance consulting in the form of regular live sessions, both scheduled and ad hoc.

Our expert walked the Client through the documentation that had to be collected in order to define the scope of HIPAA coverage and establish compliance protocols. He provided templates and examples of the necessary documents, namely:

• A Business Associate Agreement that needs to be signed by the Client and the offshore developers, outlining their responsibilities in protecting ePHI.
• HIPAA privacy policies detailing how the apps will protect patient privacy and handle ePHI.
• HIPAA security policies outlining the security measures needed to protect ePHI, including data encryption, access controls, and audit logs.
• A risk assessment report containing a thorough analysis of potential risks to ePHI along with strategies to mitigate those risks.
• Data handling procedure guidelines detailing how to collect, store, transmit, and dispose of ePHI.
• An incident response plan outlining the procedures for responding to data breaches or other security incidents, including notification requirements and mitigation steps.
• HIPAA training documentation for the Client’s employees and outsourced teams.
• App audit and monitoring plans listing the procedures for regular reviews and audits of the apps and associated systems to ensure ongoing HIPAA compliance.
• Consent forms and notices for obtaining patient consent and informing them of their rights under HIPAA.
• Data sharing agreements outlining how data will be shared with other entities, ensuring that all data exchanges are compliant with HIPAA regulations.

Following the templates and examples, the Client’s team assembled the documents needed for their project. During the following consulting sessions, our compliance officer reviewed the document drafts and answered additional questions from the Client’s team, helping them gain confidence in the relevant HIPAA policies and procedures.

HIPAA-compliant software development guidebook

In addition, ScienceSoft’s expert compiled a 30-page HIPAA guidebook for app development and maintenance. The main area of focus was the design of privacy and security policies and procedures, development infrastructure, and software architecture to achieve HIPAA compliance.

The guidebook details which parts of the HIPAA law apply to the Client’s project and specifies the compliance steps required from the offshore app development vendor.

The guidebook features a comprehensive section on risk analysis, explaining how to evaluate the likelihood and impact of potential security risks to ePHI. Our expert provided practical recommendations for implementing security measures to mitigate these risks, explained the purpose of each specific security measure, and offered guidelines on how to document these measures effectively.

The guidebook is divided into sections outlining the safeguards that need to be implemented to protect ePHI in line with the HIPAA rule.

Administrative safeguards

This subsection guides the Client on how to:

• Establish security management processes to identify and analyze PHI-related risks.
• Develop a contingency plan for security emergencies and data loss incidents.
• Check the staff’s and business associates' awareness of HIPAA policies and procedures.
• Implement effective HIPAA training for the staff and business associates to uphold compliance standards.
• Establish secure information access management policies and processes to control access to PHI.

Physical safeguards

This subsection elaborates on how the Client should:

• Implement security measures to safeguard physical access to facilities and equipment housing ePHI.
• Secure workstations and electronic media containing ePHI.
• Establish secure storage and disposal practices for physical records and electronic media that contain ePHI.

Technical safeguards

The subsection explains how to:

• Implement privacy and security policies and procedures for HIPAA-compliant app development infrastructure.
• Select HIPAA-compliant development frameworks and tools.
• Implement specific security features within the apps’ architecture, such as data encryption, access controls, and secure interfaces.
• Design and implement ePHI storage, transmission, deletion, and backup policies.
• Define and enforce ePHI access control, alteration, and distribution policies.
• Ensure that access to ePHI is restricted to authorized users and prevent improper alteration or destruction of ePHI.
• Incorporate robust transmission security measures to protect ePHI transmitted over an electronic network.
• Encrypt ePHI in transit and at rest.

The app development guidelines provided to the Client are organized into three main categories:

Development process guidelines

These guidelines help the Client embed HIPAA requirements into every phase of app development, from design to testing and deployment. They include setting up secure development environments and adhering to best practices for coding and data handling to ensure ongoing compliance.

Product-specific guidelines

The guidelines focus on the specific features and functionalities the eye diagnostics apps need to contain to protect ePHI. For example, our consultant outlined how to incorporate encryption and access controls within the apps, making sure that all data handling processes meet HIPAA standards.

Development team guidelines

These guidelines ensure that all team members involved in the app development understand and adhere to HIPAA regulations. The guidelines describe team training requirements, documentation of compliance practices, and protocols for handling ePHI.

Clear HIPAA Roadmap for Compliant App Development

Within three months, the Client gained a confident understanding of how to maintain HIPAA compliance during the development and maintenance of its eye diagnostics applications. ScienceSoft provided 40 hours of consulting sessions and a detailed, project-specific HIPAA compliance book for business analysts, software architects, tech leads, project managers, and QA engineers involved in the app development. Importantly, the guidelines also cover compliance requirements for collaboration with offshore software development vendors.

Technologies and Tools

Microsoft Teams, Microsoft Office, Google Drive, Jira.