ScienceSoft Global
How ScienceSoft Builds Compliance Into Every Stage of Healthcare Software Development
When compliance is treated like a checklist, audits become fire drills. We run an ISO-certified, NIST/OWASP-aligned SDLC with BAAs/DPAs and continuous monitoring — so inspections are routine, not emergencies.
Common Compliance Pitfalls in Healthcare Software Development
Some software vendors treat compliance as a checklist. This approach misses risks specific to the app’s workflows and healthcare contexts (e.g., bulk FHIR exports bypassing consent checks), as well as gaps that appear during updates and scaling. In a regulated healthcare environment, such shortcuts often result in audit findings and delayed certifications.
Below, we outline the most common practices that can lead to non-compliance and show what ScienceSoft maintains instead.
|
|
What goes wrong |
How ScienceSoft makes a difference |
|---|---|---|
|
Overlooking the healthcare regulatory scope
|
Some software vendors without healthcare specialization treat HIPAA as a stand-in for full compliance and miss mandates such as FDA 21 CFR Part 11 or CCPA/CPRA. These gaps often surface only during regulatory audits (e.g., FDA, OCR) or sponsor validation reviews after deployment. Thus, a healthcare provider may discover during OCR audits that audit logging lacked version control, which fails HIPAA Security Rule expectations and triggers a corrective action. Or clinical trial software may be rejected due to missing 21 CFR Part 11 traceability fields, which can delay submissions and risk trial timelines. |
With 20 years in healthcare IT, our teams are trained to identify regulatory exposure (GxP, HIPAA, HITECH, GDPR, Cures Act, TEFCA, etc.) and reflect it in a software scope from the start.
|
|
Cutting corners on security controls
|
To cut development costs or speed up delivery, software vendors may deprioritize application-layer security and push the responsibility to the client’s infrastructure teams. This leads to recurring audit failures, such as unencrypted databases, shared production credentials, or insufficient user activity tracking. When software vendors delay patching or withhold vulnerability alerts, healthcare providers face data breaches and incidents. |
Our ISO 27001-certified security management system ensures security is planned, executed, and verified across the entire software life cycle without any shortcuts.
|
|
Neglecting proper software validation and QA
|
Some software vendors release regulated healthcare software without conducting thorough regression testing or confirming continued compliance with FDA validation expectations. They may skip alignment with ISO 13485 or IEC 62304, or bypass system-level QA, e.g., backend and integration tests. As a consequence, systems fail audits for the lack of IQ/OQ/PQ documentation, receive FDA citations, or face delayed GxP approval due to poor validation packages. |
We define the validation scope to meet regulatory expectations from the outset.
|
|
Poor documentation and validation traceability
|
Software vendors without formal traceability practices expose clients to high compliance risks. Missing requirement-test-result mappings, incomplete validation records, and undocumented system changes hinder the ability to demonstrate adherence to FDA and HIPAA requirements. This gap often affects critical areas such as audit trail configuration, e-signature controls, and access restrictions, leading to failed audits and urgent remediation efforts under regulatory pressure. |
We treat documentation as a formal deliverable in each development phase.
|
|
Lack of structured compliance maintenance after go-live
|
Some software vendors adopt a point-in-time approach to compliance, with no plan for sustaining it post-launch. Clients receive unvalidated patches, outdated documentation, or incomplete change logs. When regulations evolve, the systems fall out of alignment with HIPAA, FDA, or GDPR requirements, which puts certifications, approvals, and audit outcomes at risk. |
We ensure systems stay aligned with evolving regulatory standards from go-live onward.
|
ScienceSoft’s Practices for Developing Audit-Ready Healthcare Software
Building regulatory alignment into the SDLC
Late-stage compliance retrofits are costly and often fail audits. We integrate every control, from encryption to audit trails, into design specifications, tests, and compliance documentation early, so nothing is missed downstream.
Regulatory scoping and compliance-by-design
- We identify applicable frameworks (HIPAA, HITECH, FDA 21 CFR 11/820, Cures Act, state privacy laws, etc.) during early design to ensure full regulatory coverage from the outset.
- We convert regulatory requirements into actionable user stories (e.g., minimum-necessary access, audit triggers, retention rules) so compliance is embedded directly in design and development.
- We analyze sensitive data flows and threat scenarios to integrate appropriate controls directly into the system architecture.
- Each regulatory requirement is mapped to design elements, test cases, and evidence artifacts to maintain full compliance traceability.
- After validation, we maintain compliance through ongoing monitoring of regulatory updates to keep the system aligned over time.
Defense-in-depth security aligned with healthcare regulations
- We implement role- and attribute-based access controls aligned with clinical and operational workflows.
- We integrate app login flows with enterprise identity systems (e.g., SAML or OIDC for single sign-on) and enable multi-factor authentication to meet regulatory access control mandates.
- We use encryption in transit (TLS 1.2+/1.3) and at rest (AES-class algorithms), adding field-level encryption or tokenization for data governed by stricter rules (e.g., 42 CFR Part 2).
- We design tamper-evident audit logs with retention controls and integrate them into security monitoring tools (e.g., SIEM) to detect and alert on suspicious or large-scale access attempts.
- We embed secure coding and dependency checks (static/dynamic analysis) into CI/CD pipelines to prevent vulnerabilities early.
- We apply hardening measures such as network segmentation and container security, aligned with NIST and OWASP recommendations, to reduce attack surfaces.
Interoperability and data exchange aligned with anti-blocking mandates
- We design FHIR R4–based API layers using widely adopted authentication standards (OAuth2, SMART on FHIR) to support compliance with USCDI interoperability requirements.
- We implement bulk data export capabilities to support analytics, migration, and patient-directed access while maintaining security and traceability.
- Our interoperability approach aligns with the Cures Act information-blocking provisions by providing documented API specifications, clear access terms, and defined exception workflows to reduce regulatory risk.
- We enable compatibility with mixed environments by supporting standard formats such as HL7 v2/v3, CCDA, and DICOM for smooth integration with legacy systems.
- We maintain USCDI-aligned terminology across exchanges (SNOMED CT for conditions, LOINC for labs, RxNorm for meds) and provide mappings to ICD-10 and CPT where required by downstream workflows.
Regulatory-grade validation and QA
- We create validation plans aligned with FDA guidelines and industry standards (e.g., GxP, IEC 62304) to ensure safety and regulatory readiness where required.
- Key compliance controls, such as privacy safeguards, security mechanisms, electronic signatures, and rollback features, undergo both automated and manual testing under documented change control.
- Each project includes a full set of technical and validation documents (traceability matrices, test reports, validation summaries, configuration logs, etc.) structured to support audits and regulatory submissions.
- We provide audit export capabilities (e.g., access logs, consent records) to help organizations respond efficiently to OCR, FDA, or internal audits.
Post-launch compliance monitoring and lifecycle management
Compliance gaps often emerge after go-live when patches or regulatory changes aren’t tracked. ScienceSoft addresses this by monitoring rule updates, validating each release, and maintaining audit-ready documentation over time.
Continuous compliance and regulatory change management
- As part of managed services, we track updates from key regulators (e.g., OCR, FDA, ONC, and state-level authorities) and evaluate how they affect deployed software and configurations.
- We provide timely advisories on patches, dependency upgrades, and hotfixes based on vulnerability severity and regulatory timelines.
- Routine compliance scans identify issues such as encryption gaps or misconfigured logging across environments.
- We help clients close identified gaps quickly by coordinating fixes, validating changes, and maintaining updated compliance records.
Mitigation and modernization strategies for legacy software compliance
- We assess all legacy systems for compliance risks, including vulnerabilities, missing audit trails, PHI exposure, and support status.
- For systems that cannot be modernized immediately, we apply compensating controls (such as network isolation, enhanced monitoring, encrypted storage, and strict access management) tailored to the system limitations and regulatory needs.
- We develop phased modernization and archival strategies aligned with retention and regulatory needs to help organizations transition safely from legacy to modern platforms.
- Our assessments prioritize compliance risks and provide actionable roadmaps for remediation and modernization planning.
Contractual compliance and third-party risk assurance
Healthcare providers face growing scrutiny over software vendor and subcontractor compliance. We prepare standard agreements (BAA, DPA) and enforce controls across all suppliers to ensure a continuous chain of compliance accountability.
Compliance contracting and audit support
- We provide HIPAA-compliant BAAs and GDPR/CPRA-aligned DPAs as a standard part of project initiation. The contractual terms are customized to each client’s specific data flows and risk models.
- We provide structured technical evidence (design specs, validation reports) needed for clients’ compliance reviews and submissions.
- Our development processes align with the ISO 27001 family of standards, and we can support clients pursuing certifications such as HITRUST or SOC 2.
Supply chain oversight and third-party risk control
- We inventory all third-party tools and services used in development (e.g., hosting environments, CI/CD pipelines) and assess their compliance impact to define required safeguards and audit evidence.
- We extend compliance requirements to subcontractors through formal agreements and oversight processes to maintain accountability.
- If a subcontractor issue arises, we notify the client without delay and jointly manage the investigation to safeguard client data and preserve regulatory compliance.
Key Regulatory Frameworks We Adhere To in Healthcare Software Design
Some healthcare software development projects have to follow multiple regulatory frameworks, primarily HIPAA, FDA guidelines, and state privacy laws, and occasionally GDPR when serving global users. We design solutions to handle this complexity from the start.
Where frameworks conflict (e.g., HIPAA retention vs. 42 CFR Part 2 consent limits), we apply harmonization strategies such as granular data classification, configurable retention policies, and jurisdiction-based controls to satisfy all applicable mandates without compromising compliance.
| US federal regulations — mandatory for software handling PHI or supporting clinical workflows | |
| HIPAA and HITECH Act |
Scope: applies to all software handling Protected Health Information (PHI) for covered entities and their business associates. HITECH extends HIPAA obligations to cloud providers and strengthens breach notification rules. Key requirements:
|
| FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures |
Scope: applies to software used in FDA-regulated environments (clinical trials, device manufacturing, research data management). Key requirements:
|
| FDA 21 CFR Part 820 — Quality System Regulation (QSR) for Medical Devices |
Scope: applies to software classified as a medical device or supporting device manufacturing/testing. Key requirements:
|
| 21st Century Cures Act and ONC Health IT Certification |
Scope: applies to certified EHR systems and health IT supporting patient access and interoperability. Key requirements:
|
| 21st Century Cures Act and ONC Health IT Certification |
Scope: applies to certified EHR systems and health IT supporting patient access and interoperability. Key requirements:
|
| 42 CFR Part 2 — Confidentiality of Substance Use Disorder Records |
Scope: applies to systems handling behavioral health or substance use disorder treatment records. Key requirements:
|
| US state privacy regulations — apply to non-HIPAA health data | |
| State Privacy Laws (e.g., CCPA/CPRA, Colorado, Virginia Privacy Acts — quickly expanding) |
Scope: apply when software processes consumer health data outside HIPAA’s scope (e.g., wellness apps, direct-to-consumer health services). Key requirements:
|
| Important non-US regulations — mandatory for software handling EU health data | |
| GDPR (EU) |
Scope: applies to software processing health data of EU residents (e.g., telehealth, clinical trial solutions). Key Requirements:
|
| Security and compliance frameworks — voluntary, widely adopted for audits | |
| NIST CSF, PF, and RMF frameworks and related standards (NIST SP 800-53, SP 800-66) |
Key features: provides structured controls for aligning with HIPAA safeguards and assessing security posture. Why it matters: widely used by US healthcare providers and software vendors as a baseline for internal audits and risk assessments. |
| HITRUST Common Security Framework (CSF) |
Key features: harmonizes HIPAA, NIST, and ISO standards into a certifiable framework. Why it matters: helps healthcare organizations quickly verify software vendor security and reduce their compliance assessment workload. |
| 405(d) Health Industry Cybersecurity Practices (HICP) |
Key features: HHS-endorsed guidance addressing top healthcare threats. Why it matters: provides actionable best practices for building secure, compliant healthcare software architectures. |
What Our Healthcare Clients Say
Malmö University turned to ScienceSoft for IT consulting on medical software development. They proved to have vast expertise in the Healthcare and Life Science industries related to the development of desktop software connected to laboratory equipment, a mobile application, and a data analytics platform.
They bring top-quality talents and deep knowledge of IT technologies and approaches in accordance with ISO13485 and IEC62304 standards.
