Powerful Medical Achieves SOC 2 Type II and HIPAA Compliance Through External Audit
Powerful Medical is proud to announce the successful completion of both SOC 2 Type II and HIPAA compliance audits conducted by the globally recognized audit firm BDO, underscoring our commitment to upholding the highest standards of data security, privacy, and operational excellence in the healthcare technology sector.
Powerful Medical is proud to announce the successful completion of both SOC 2 Type II and HIPAA compliance audits conducted by the globally recognized audit firm BDO. This achievement underscores our unwavering commitment to upholding the highest standards of data security, privacy, and operational excellence in the healthcare technology sector.
Independent Verification of Data Security and Privacy Controls
Achieving SOC 2 Type II certification demonstrates that Powerful Medical has established and maintained rigorous controls across critical areas such as security, availability, processing integrity, confidentiality, and privacy. This independent assessment affirms that our systems and processes not only meet but surpass the stringent criteria necessary to ensure the protection of sensitive information in a healthcare environment.
Additionally, obtaining HIPAA compliance confirms that we adhere to the comprehensive regulatory framework required for safeguarding protected health information (PHI) in the United States. Both certifications reflect our proactive approach to maintaining compliance with international and national data protection standards, which are essential for ensuring the security of patient data and the trust of our partners and clients.
Security & privacy standards that keep your data safe
Fostering Innovation Through Compliance and Reliability
As a leader in AI-powered medical technologies, Powerful Medical is dedicated to driving innovations that improve patient outcomes while adhering to the most stringent regulatory standards. These certifications not only validate our robust internal controls but also serve as a testament to our ongoing commitment to transparency, security, and data integrity in the medical device sector.
In a landscape where data security and privacy are paramount, achieving SOC 2 Type II and HIPAA compliance strengthens our position as a trusted partner to healthcare providers, regulatory bodies, and patients worldwide. These certifications are now available for review in our Trust Center, offering full visibility into the measures we have implemented to safeguard sensitive information.
A Commitment to Trust and Excellence
At Powerful Medical, we believe that trust and innovation go hand-in-hand. By continuously refining our security practices and achieving critical compliance milestones, we remain at the forefront of delivering secure, compliant, and transformative healthcare technologies.
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About PMcardio
PMcardio is a CE-marked Class IIb AI medical device that interprets any 12-lead ECG — from a photo or a digital file — in seconds. It detects 50+ ECG findings, including occlusion myocardial infarction (OMI) — the acute coronary occlusions that conventional STEMI criteria miss in over half of cases. Its Queen of Hearts™ OMI model holds FDA Breakthrough Device Designation, and PMcardio is already used by 100,000+ clinicians who have analyzed more than 2.5 million ECGs.
About Powerful Medical
Powerful Medical is a medical-technology company using artificial intelligence to transform how cardiovascular disease — the world’s leading cause of death — is diagnosed. Founded in 2017, it built PMcardio, the world’s first AI medical device to detect acute coronary occlusion (OMI) from an ECG. Its research is published in the European Heart Journal – Digital Health and validated across 25+ clinical studies, and its Queen of Hearts™ model earned FDA Breakthrough Device Designation. To date, PMcardio has supported the detection of 120,000+ heart attacks across 150+ hospital deployments worldwide.
