Segmed Achieves Independent HIPAA Certification for Imaging and Clinical Data
Segmed, Inc., a prominent name in the realm of real-world medical imaging data utilized for research and AI development, has taken a significant step in ensuring the compliance and privacy of its data handling practices. On January 6, 2026, the company proudly announced that it has successfully secured an independent Expert Determination, indicating that its structured clinical data, medical imaging pixels, and radiology text adhere to the stringent HIPAA de-identification standards.
The Health Insurance Portability and Accountability Act (HIPAA) plays a critical role in safeguarding individuals' medical records and personal health information. For organizations dealing with health data, ensuring compliance with HIPAA is not merely a legal obligation but also a moral one, aiming to protect patient confidentiality and data integrity. Expert Determination is one of the two officially recognized methods under HIPAA, allowing for the de-identification of health data. Here, a qualified privacy expert evaluates whether there is any reasonable chance of the information being used to identify an individual.
What sets Segmed apart from other entities is its robust strategy in approaching the de-identification of various data modalities. The validation conducted highlights the effectiveness of Segmed’s method, encompassing a mixture of automated algorithms coupled with rigorous human quality reviews across all relevant data types. This meticulous process ensures that direct identifiers are thoroughly removed, while indirect identifiers are scrutinized and suppressed as necessary to mitigate any risk of re-identification.
Dr. Brad Malin, the statistical expert who conducted the Expert Determination, stated, "These determinations reflect a careful, methodical assessment of Segmed's de-identification practices. Based on my evaluation, it is my opinion that Segmed's database meets the HIPAA standard for de-identified data." This validation not only confirms Segmed's commitment to privacy but also ensures that their datasets can be used compliantly in various contexts, including AI development, pharmaceutical research, and clinical advancements.
David Gascoigne, the CEO of Segmed, emphasized that trust is a cornerstone of their operations. The achievement of independent Expert Determination reinforces Segmed's dedication to privacy, compliance, and responsible data stewardship. It provides confidence to their partners, allowing them to innovate effectively using real-world imaging data in a compliant and scalable manner.
In addition to the recent Expert Determination, Segmed has been maintaining SOC 2 Type 2 and ISO 27001 certifications. These certifications denote Segmed's ongoing investment in security, governance, and operational excellence, covering their information security management systems and internal controls. Such certifications are routinely audited to ensure adherence to industry best practices, further exemplifying Segmed’s commitment to maintaining rigorous security protocols.
With rising demand for high-quality and privacy-compliant real-world data, Segmed is devoted to evolving its infrastructure to meet both scientific and regulatory expectations. They work closely with healthcare providers, life sciences companies, and technology partners to promote the responsible use of medical imaging and clinical data on a global scale.
Segmed, Inc. is committed to facilitating access to diverse, high-quality real-world data, including both medical imaging and clinical records. Their focus is directed toward biopharmaceutical research and development, AI innovation, and medical device advancement. By leveraging a global network of healthcare partners across five continents, Segmed offers researchers access to approximately 150 million de-identified and standardized imaging datasets. This initiative empowers a safer, faster, and equitable advancement in healthcare solutions. For more information, visit www.segmed.ai or follow them on LinkedIn.
Understanding HIPAA and Its Significance
The Health Insurance Portability and Accountability Act (HIPAA) plays a critical role in safeguarding individuals' medical records and personal health information. For organizations dealing with health data, ensuring compliance with HIPAA is not merely a legal obligation but also a moral one, aiming to protect patient confidentiality and data integrity. Expert Determination is one of the two officially recognized methods under HIPAA, allowing for the de-identification of health data. Here, a qualified privacy expert evaluates whether there is any reasonable chance of the information being used to identify an individual.
Segmed’s Comprehensive Approach to De-Identification
What sets Segmed apart from other entities is its robust strategy in approaching the de-identification of various data modalities. The validation conducted highlights the effectiveness of Segmed’s method, encompassing a mixture of automated algorithms coupled with rigorous human quality reviews across all relevant data types. This meticulous process ensures that direct identifiers are thoroughly removed, while indirect identifiers are scrutinized and suppressed as necessary to mitigate any risk of re-identification.
Dr. Brad Malin, the statistical expert who conducted the Expert Determination, stated, "These determinations reflect a careful, methodical assessment of Segmed's de-identification practices. Based on my evaluation, it is my opinion that Segmed's database meets the HIPAA standard for de-identified data." This validation not only confirms Segmed's commitment to privacy but also ensures that their datasets can be used compliantly in various contexts, including AI development, pharmaceutical research, and clinical advancements.
Trusting Data Stewardship
David Gascoigne, the CEO of Segmed, emphasized that trust is a cornerstone of their operations. The achievement of independent Expert Determination reinforces Segmed's dedication to privacy, compliance, and responsible data stewardship. It provides confidence to their partners, allowing them to innovate effectively using real-world imaging data in a compliant and scalable manner.
Certifications and Continued Commitment
In addition to the recent Expert Determination, Segmed has been maintaining SOC 2 Type 2 and ISO 27001 certifications. These certifications denote Segmed's ongoing investment in security, governance, and operational excellence, covering their information security management systems and internal controls. Such certifications are routinely audited to ensure adherence to industry best practices, further exemplifying Segmed’s commitment to maintaining rigorous security protocols.
A Future-Focused Organization
With rising demand for high-quality and privacy-compliant real-world data, Segmed is devoted to evolving its infrastructure to meet both scientific and regulatory expectations. They work closely with healthcare providers, life sciences companies, and technology partners to promote the responsible use of medical imaging and clinical data on a global scale.
About Segmed
Segmed, Inc. is committed to facilitating access to diverse, high-quality real-world data, including both medical imaging and clinical records. Their focus is directed toward biopharmaceutical research and development, AI innovation, and medical device advancement. By leveraging a global network of healthcare partners across five continents, Segmed offers researchers access to approximately 150 million de-identified and standardized imaging datasets. This initiative empowers a safer, faster, and equitable advancement in healthcare solutions. For more information, visit www.segmed.ai or follow them on LinkedIn.
Topics Health）
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