CISO’s Medical Device Security Risk Assessment Guide for Medical Device Procurement

By Jeremy Linden, Sr. Director of Product Management, Asimily

The first step in delivering excellent care for patients and defending their private health information is medical device procurement that can empower your team. New equipment can assist your personnel, but it’s difficult to gauge the risks immediately. Therefore, conducting a thorough security risk assessment is so important. Doing your due diligence before purchasing protects your investment and supports healthy patient outcomes.

The chief information security officer (CISO) has a duty to protect an organization’s data. This can prove particularly difficult in the healthcare industry, given the privacy regulations and common technical challenges.

Asimily’s ProActive offers an effective solution for providers to conduct a medical security risk assessment for medical device procurement. We collate information from various sources and process the data into an accurate and user-friendly summary to gauge products before buying. Receive more device information than any other source to conduct an accurate, detailed security risk assessment. 

Medical Device Procurement: Challenges of Security Risk Assessments

When you’re purchasing medical equipment, there’s always a risk of the device not adequately serving its purpose. Conducting a medical device security assessment identifies potential problems before they materialize. It’s much better to prevent an issue beforehand than to have to resolve it later. As the saying goes, “an ounce of prevention is worth a pound of cure.”

Regulations requiring security risk analyses before medical device procurement have complicated the situation since governments generally don’t offer clear, regularly updated guidelines on assessing the risks. While some companies have conducted risk analyses just for compliance, this is questionable at best and doesn’t improve security.

Healthcare provider organizations need more than an arbitrary checklist. They need useful processes to assess risks before procurement.

Why Perform Medical Device Security Assessments At All? 

Regulatory practices aside, risk assessments are conducted to stay one step ahead of burgeoning threats to medical devices. Risk measures the likelihood of an adverse event occurring coupled with the impact that such an event might have on your organization. Regular security risk assessments are, therefore, a core aspect of medical device security.

To initiate the process, the US government offers resources to help organizations adhere to HIPAA standards. These resources advise users on assessing risks and taking technical and administrative steps to increase data security. But while the government only offers general guidance, each organization determines specific action items for regulatory compliance.

Any institution that uses devices handling electronically protected health information is legally obligated to assess risks and take reasonable precautions. However, this remains a public duty even if not legally mandated. since a lack of safeguards exposes sensitive data to criminals and accidents. It’s unsafe for patients to use medical devices with unknown risks.

The results of a security risk assessment can inform smart medical device procurement processes now and in the future. Security risk assessments can also help improve data transmission and encryption processes to inform your authentication system design.

The Complexities of the Medical Device Procurement Process

Medical device procurement has become extremely important as healthcare technology now plays a central role in medicine. Yet the procurement process is complex, fraught with a wide range of challenges, and can take up to a full year to complete.

To start, one generally receives information about devices from a range of sources, which aren’t necessarily consistent. For example, you may learn about medical devices from colleagues, vendors, or online references. There are also conflicting priorities beyond security, including patient care quality, cost, and speed of operations.

The teams making purchase decisions often include doctors, administrators, and directors, among many other groups not well-versed in security. Even those who do know about IT security may not be experts in medical devices. Ensuring the right people with the right knowledge guide every single procurement is crucial.

Shared responsibilities sometimes lead to gaps where duties aren’t clearly defined, and these gaps are where security problems occur. Inconsistent medical device procurement processes can also bring high-risk devices onto the network. When forcing a variety of new and old devices to interoperate, it’s important to remember that each device brings along hardware and software from complex supply chains, each with its own risks.

These and other difficulties make medical devices a unique challenge to secure. Fortunately, Asimily offers a custom-made solution to solve this problem.

Asimily: A Robust Risk Analysis Approach to Medical Device Security

Asimily offers a practical solution for your organization to analyze risks before procurement. ProActive collects data from multiple systems and combines the information into a usable security risk assessment for medical devices.

The results provide actionable information on device configurations, rating each configuration’s risk and potential impact on your organization. Insights from other networks can further inform your organization’s decisions on which devices are safe to use.

ProActive crowdsources data from millions of live points around the world. It also incorporates information from manufacturers and customers, and even our own research, to give you unbeatable risk assessments. Medical device procurement has never been this easy.

No other solution has as much information or makes it as straightforward. Asimily helps you understand the risk of each device with data from hundreds of thousands of similar devices already at work within our customer base. A simple report provides information about any device of interest, and you can simulate different configurations to see how they affect total risk.

Detailed MDS 2 manufacturer information rounds out the ProActive repository. Asimily’s security research combines unparalleled data to provide simple-to-use information on the most secure device models. Even after procurement, you can use these insights to harden devices.

Medical Device Procurement, the Asimily Way

Risk analysis is a critical part of safely procuring medical devices. While governments mandate risk analyses for procurement, they haven’t offered enough useful information for healthcare providers to do so effectively, making assessing risks before buying difficult.

The solution is to use a tool custom-built to provide security for the Internet of Medical Things (IoMT). Asimily’ is the leading system to analyze medical device risks, making procurement safe and easy.

Schedule a demo to see how Asimily can cut your operational inefficiencies and device downtimes today!

Reduce Vulnerabilities 10x Faster with Half the Resources

Find out how our innovative risk remediation platform can help keep your organization’s resources safe, users protected, and IoT and IoMT assets secure.