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Segmed secures independent HIPAA Expert Determination across imaging and clinical data

A sleek, black Segmed logo (PRNewsfoto/Segmed)

News provided by

Segmed

Jan 06, 2026, 08:02 ET

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PALO ALTO, Calif., Jan. 6, 2026 /PRNewswire/ -- Segmed, Inc., a leader in real world medical imaging data for research and AI development, today announced that it has secured an independent Expert Determination confirming that its structured clinical data, medical imaging pixels, and radiology text meet the HIPAA de-identification standard.

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A unified de-identification pipeline for clinical data and medical imaging — HIPAA compliant by design.
A unified de-identification pipeline for clinical data and medical imaging — HIPAA compliant by design.

Expert Determination is one of the two official pathways recognized under HIPAA for de-identification of health data. Through this process, a qualified statistical privacy expert determines that there is no reasonable basis to believe that the information could be used to identify an individual.

The three determinations independently validate Segmed's de-identification approach across all major data modalities used in modern healthcare research. This includes structured clinical fields, imaging pixel data, and unstructured radiology text, which are often among the most challenging data types to de-identify at scale.

Segmed's de-identification process combines automated algorithms with human quality review across all data types. Direct identifiers are removed, and indirect identifiers are systematically evaluated and suppressed where necessary to reduce re-identification risk. This hybrid approach is designed to balance privacy protection with preservation of data utility for downstream research and development.

"These determinations reflect a careful, methodical assessment of Segmed's de-identification practices," said Brad Malin, PhD, the statistical expert who conducted the Expert Determination. "Based on my evaluation, it is my opinion that Segmed's database meets the HIPAA standard for de-identified data."

The validation supports compliant commercial use of Segmed's datasets for AI development, pharmaceutical research, and clinical innovation. As regulatory scrutiny around data provenance and privacy continues to increase, independent verification of de-identification practices is becoming a critical requirement for organizations working with real world health data.

"Trust is foundational to everything we do," said David Gascoigne, CEO of Segmed. "Securing independent Expert Determination across structured data, imaging pixels, and radiology text reinforces our long-standing commitment to privacy, compliance, and responsible data stewardship. It also gives our partners confidence that they can innovate using real world imaging data in a compliant and scalable way."

In addition to the Expert Determination, Segmed has maintained SOC 2 Type 2 and ISO 27001 certifications for several years, reflecting a sustained investment in security, governance, and operational rigor. These certifications cover Segmed's information security management systems and internal controls, and are regularly audited to ensure ongoing compliance with industry best practices.

As demand grows for high-quality, privacy-safe real world data, Segmed continues to focus on building infrastructure that meets both scientific and regulatory expectations. The company works closely with healthcare providers, life sciences companies, and technology partners to enable responsible use of medical imaging and clinical data at global scale.

About Segmed
Segmed, Inc. streamlines access to diverse, high-quality real-world data, including medical imaging and clinical records, for biopharmaceutical R&D, AI development, and medical device innovation. With a global network of healthcare partners across five continents, Segmed provides researchers with approximately 150 million de-identified, standardized imaging datasets through its proprietary platform, empowering safer, faster, and more equitable healthcare advancements. For more information, visit www.segmed.ai or follow us on LinkedIn @segmed-ai.

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