Industry Leading Cyber Risk Management & HIPAA Compliance Solutions for Medical Device Manufactures

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Clearwater provides medical device manufacturers with best-in-class cyber risk management solutions that enable them to reduce the likelihood of a breach, save time and money, and meet HIPAA compliance requirements.

Device manufacturers that receive or maintain information that is individually identifiable and contains health data—otherwise known as electronic protected health information (ePHI)—are required to comply with HIPAA’s Privacy, Breach Notification, and Security Rules. Traditionally, medical device companies have received ePHI to assist providers in determining the appropriate device or plan a surgery. However, in today’s world of digital health, the amount of ePHI device manufacturers receive is growing as they become more connected to and integrated with healthcare delivery. Many are assisting with patient care management through devices such as pacemakers, glucose monitors, insulin pumps, and other “smart” devices, recording a variety of real-time data with a patient name or other type of patient identifier.

With cyber attacks increasing in complexity and number, the threat of a security breach is greater than ever before, and the stakes have never been higher. Conducting on-going risk analysis and risk management are not only key requirements of the HIPAA Security Rule, and FDA regulations, but also the foundation of a device manufacturer’s security program. Device manufacturers must implement a best-in-class cyber risk management solution to ensure they have appropriate security controls in place to avoid a breach.

Clearwater’s team of HIPAA Compliance and Cybersecurity experts has partnered with hundreds of healthcare customers and with some of the largest device manufacturers, delivering highly-scalable cyber risk management solutions that conform to the specific needs of each organization. The combination of our IRM|Pro® SaaS platform, our experienced professional services, and our proven methodology, provides your company with a comprehensive solution that maps to its specific environment, protects your data, saves you time and money, and ensures compliance with HIPAA.

Clearwater provides you with a scalable, long-term solution for implementing your risk assessment, risk remediation, and compliance assessment processes. You will quickly identify where your largest exposures exist, and leverage actionable insights to rapidly reduce risk, while simultaneously documenting the process.

Contact Clearwater to learn more about our solutions for medical device manufacturers.