Mahana Therapeutics Achieves Key Quality Control Credentials

With SOC 2® Type II report certification and Cyber Essentials accreditation, Mahana brings industry-leading quality control in digital therapeutics

SAN FRANCISCO–(BUSINESS WIRE)–Mahana Therapeutics, a leading developer of digital therapeutics designed to empower people with chronic conditions to lead fuller lives, today announced that it has completed Service Organization Control (SOC) 2 Type II audit for its world class digital therapeutic offering. This comprehensive third-party audit and certification verifies that the company meets the highest standards of security and compliance in its data management practices. The company also achieved Cyber Essentials accreditation in the United Kingdom.

“Mahana Therapeutics is proud to complete these important certifications, underscoring our commitment to the highest possible data management and quality standards for our customers,” said Simon Levy, co-founder and CEO of Mahana Therapeutics. “We believe this raises the bar for all digital therapeutics companies and ensures that our emerging industry embraces best data practices from the start.”

Digital therapeutics such as the FDA-cleared Mahana IBS offer the opportunity to help patients prevent, manage, and treat health conditions. Data privacy and security is of the utmost importance to patients and providers when it comes to health information. SOC Type II certification demonstrates that Mahana has implemented the highest standards to provide assurance for customers around data privacy and security controls.

SOC 2 Type II certification was developed by the American Institute of Certified Public Accountants as part of its System and Organization Controls (SOC) for Service Organizations. The compliance report provides detailed information about an organization’s controls for security, access, confidentiality, and integrity in processing customer data. SOC 2 Type II reports are critical for regulatory oversight, risk management, and internal governance. Once SOC 2 certification has been achieved, companies undergo annual audits to maintain compliance.

Cyber Essentials is a UK quality accreditation typically required for doing business with the National Health Service. Certification indicates that an organization has taken all recommended steps to ensure cyber security and to protect its data.

“I am proud of the entire Mahana team for undertaking these rigorous quality programs and achieving compliance with SOC 2 and with Cyber Essentials,” said Kendal Dinsmore, VP of Global Regulatory Affairs & Quality Assurance, at Mahana Therapeutics. “As we work toward ISO 27001 certification this year for data security, these successes validate that our approach is safe and secure.”

Mahana Therapeutics offers Mahana IBS; an FDA-cleared, UKCA marked, prescription digital therapeutic that provides gut-directed cognitive behavioral therapy as a 3-month treatment to adults with irritable bowel syndrome. The prescription is available through a downloadable app available for iOS and Android phones and tablets. Based on 20 years of research, Mahana IBS provides cognitive behavioral therapy which helps patients change their behaviors and thoughts, decreasing the severity of IBS symptoms. Mahana IBS may be used with other IBS treatments.

About Mahana Therapeutics

Mahana Therapeutics is a leading developer of prescription digital therapeutics that are designed to empower patients with chronic conditions to live fuller lives. The company’s first product, Mahana IBS, was the first digital therapeutic to receive FDA clearance for the treatment of IBS and provides cognitive behavioral therapy (CBT) to adults with IBS. More information is available at


Michele Parisi



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