Backbone Consultants has the technical expertise to assist organizations navigate through complex security and compliance challenges associated with medical devices. Medical Device Manufacturers (MDMs) and Healthcare Delivery Organizations (HDOs) are increasingly becoming a high-risk consideration for regulators. The risk profile for medical devices are much different than most business systems and require knowledgeable professionals to properly assess cybersecurity and data privacy threats and the associated risks.
While, atypical security risks presented in business applications could impact a company’s financials or operational capabilities, security vulnerabilities within medical devices have the potential to directly result in patient harm or modification to medical data. Most organizations are unwilling to undertake and accept this level of risk and therefore it is critical to engage professionals that have the capability to mature these programs.
To help mitigate these risks the Food and Drug Administration (FDA) has published recommendations for cybersecurity design and management of vulnerabilities for medical devices. Backbone’s team of experts can help your organization with technical analysis and testing of medical device systems (e.g. physical devices, associated mobile applications, and other system integrations), as well as compliance with regulatory requirements, including but not limited to FDA Premarket and Postmarket guidance. Backbone’s Medical Device Security Services capabilities include but are not limited to:
Healthcare Delivery Organizations Cybersecurity Risk Assessments: Backbone can help HDOs understand and manage the compliance and security risks as healthcare tools and technologies increasing collect, report, and network with external systems. Our team of trained experts can help manage these risks by performing a cybersecurity risk assessment tailored to understand where your organization may have exposure and subsequently assist with recommendations on how best to mitigate risk.
Technical Evaluation of Medical Products & Systems: Backbone can help evaluate your company’s medical devices or related healthcare systems for known vulnerabilities, security threats, or the ability to manipulate application functionality or data. Through a combination of secure coding practices, architecture review, penetration testing and other techniques a client will gain confidence with their premarket devices and supporting systems.
Postmarket Vulnerability Management & Reporting: Backbone can help your organization mature processes related to evaluation of healthcare system or medical device vulnerabilities, assist in the assessment of risk severity by leveraging industry standard risk scoring processes (e.g. CVSS), risk remediation activities, determination if the identified risks are controlled or uncontrolled, as well as reporting requirements mandated by the FDA.
As the medical device and healthcare industries continue to move towards smart technologies that support greater connectivity, there is an increased need to manage the complex compliance, privacy, cybersecurity, and other emerging risks associate. This is where Backbone can be your ally and long-term strategic partner.
Backbone’s certified information system security professionals (CISSP) and certified information system auditors (CISA) will help build maturity into your organization’s Medical Device Security program and ensure a greater level of compliance and risk management. Tap into our team of professionals today to bolster your company’s medical device security capabilities.