The Indian medical device industry considers the US FDA's draft pre-market cybersecurity guidance to be a valuable document. According to the industry, this provides reasonable assurance that the device and associated systems are cyber secure. As remote patient monitoring and telemedicine have become core services in healthcare, many companies have already begun expanding their medical device cybersecurity services portfolios. This is to enable uniform levels of security, visibility, traceability, and auditing capabilities required for critical access management and data security.
The US FDA's guidance on selecting updates for premarket cybersecurity mandates the need for device manufacturers to design, develop, and maintain processes and procedures.
According to medical device industry officials here, the guidance is of critical importance for India and provides a roadmap to ensure cybersecurity of devices and related systems, thereby improving market access, customer confidence and risk. It said it would strengthen mitigation efforts, competitive position and legal regulations. compliance.
Hospitals conduct regular risk assessments, implement robust security protocols, ensure staff training on cybersecurity best practices, and collaborate with cybersecurity experts to identify and address vulnerabilities in medical devices and hospital networks. The priority of cybersecurity measures is increasing. Additionally, regulatory bodies and policy makers play a critical role in establishing and enforcing cybersecurity standards that protect patient care and data privacy in the healthcare sector, the Indian medical device company said.
In their guidance, global regulators have emphasized the need for medical device software updates, including validation. This is because more devices are connected to the internet. It contains technical features that may make it vulnerable to cybersecurity threats. These include Wi-Fi or cellular network, server, or cloud service provider connections. Additionally, Bluetooth, radio frequency communication. Hardware connectors that can connect to the Internet: USB, Ethernet, and serial ports that require validation.
Under the Documentation Recommendations for Compliance section for the applicable premarket submission type, manufacturers must provide documentation to comply with the requirements under Section 524B of the FD&C Act.
In this regard, global regulators have suggested three steps. The first is to monitor and identify post-market cybersecurity vulnerabilities and exploits, including tailored vulnerability disclosures and related steps that medical device companies must disclose in pre-market applications, and for an appropriate period of time. Make a plan to deal with it internally.
Second, regulators must develop and release necessary updates to cyber devices to ensure that known unacceptable vulnerabilities can be detected on reasonably justified regular cycles. is claimed. Companies need to address critical out-of-cycle vulnerabilities as soon as possible that can pose uncontrollable risks.
Third, the U.S. FDA recommends that cyber device manufacturers anticipate and update these plans, processes, and procedures as appropriate. This helps medical device companies address new risks, threats, vulnerabilities, and adverse effects as they are discovered throughout the product lifecycle. “To support such efforts, manufacturers must also create or update appropriate documentation and maintain it throughout the device lifecycle,” the global regulator said.
