Remote access in the health care and medical device environment refers to the capability of accessing and managing medical systems, devices and data from a location outside of the physical premises. As more and more medical device types become interoperable, the desire by manufacturers to leverage remote access to improve reliability, reduce costs and enhance customer service has become commonplace.
This ecosystem of services encompasses various functionalities such as remote software updates, diagnosis, repair, assistance, training, proactive monitoring and predictive maintenance. However, remote access also introduces a plethora of risks and challenges, particularly concerning security and compliance.
One of the primary challenges associated with remote access is the lack of established protocols and standards. With numerous means and methods utilized for remote access, there is a pressing need for comprehensive policies to govern these activities and control ad-hoc methods effectively. Additionally, unsecured networks pose significant threats, potentially allowing malicious actors to infiltrate the health care provider’s infrastructure and the remote technician’s system.
Impersonation presents another critical risk, as inadequate authentication measures may enable unauthorized individuals to gain access under false pretenses. Moreover, the transfer of unauthorized software during remote sessions can compromise system hygiene and integrity. Unauthorized access, coupled with poor visibility into remote actions and insufficient change management, further exacerbates the security concerns surrounding remote access.
Standards such as ISO 27001 for Information Security Management Systems and FIPS 140-2, Security Requirements for cryptographic modules help organizations develop, deploy and operate computer environments securely. No standard exists for vendor remote access to serve as a benchmark for data, application, network and physical security. Manufacturers, providing a spectrum of services, may train their staff on a preferred tool. Manufacturers and vendors often have preferred remote access tools that best fit the needs of their organization. Policies, practices, controls and training are optimized for the preferred solution. However, compliance with non-native systems may introduce additional risks, emphasizing the importance of establishing trust between stakeholders. This trust can be fostered through comprehensive training, certification programs and adherence to clinical usage protocols.
Redefining trust in the context of remote access involves considering both human interactions and machine-to-machine (M2M) communications. Human interactions are fraught with variables and potential vulnerabilities that can be limited with well-understood policies and controls. Reducing variability and minimizing unattended human-to-machine (H2M) sessions, automation can enhance trust by facilitating autonomous actions, transmitting alerts and alarms, and enabling asset tracking for performance monitoring and mitigation of potential issues.
Understanding the risks of remote access requires a holistic approach, encompassing the reasons for access, the extent of access granted, the methods employed, the implemented controls and the initiation processes.
By systematically evaluating these factors, health care organizations can mitigate risks effectively and ensure their systems and data security and integrity. The support use cases may include remote assistance, remote training or remote diagnosis. Do these all require root access to the device? There should be minimal required access rights just as if accessing the machine through the control panel. Remote service technicians and all activities should also follow change management controls and should be adequately logged. M2M access for proactive and predictive monitoring or to provide and install updates or patches when agreeably configured can improve reliability, increase trust and decrease costs,
In conclusion, remote access plays a crucial role in the health care and medical device environment, enabling efficient management and maintenance of critical systems and devices. However, this convenience comes with inherent risks, including security vulnerabilities and compliance challenges. To navigate these risks successfully, stakeholders must prioritize the establishment of robust protocols, adherence to security standards, and cultivating trust through comprehensive training and certification programs. Only through proactive risk management and vigilant oversight can health care organizations harness the benefits of remote access while safeguarding patient safety and data confidentiality.