Medical devices are one of those product categories that, thanks to high-tech, are evolving at an incredible speed, increasingly integrating information technology. Innovations in medical devices offer significant benefits. But they also bring with them serious dangers.

What are the dangers of modern medical equipment?

Thanks to information technology, medical equipment, databases, networks, and, ultimately, patient data can become the target of cyberattacks. New risks challenge regulators around the world, and regulators are responding. For example, in early 2020, information security guidelines were introduced in Europe to cover all manufacturers of medical software and equipment that use software and information technology.

The FDA has also developed a similar standard, but the US regulator has not yet been given binding status. It is advisory. Nevertheless, the FDA’s information security criteria for medical devices set out in the guidelines are worth considering. This makes the product registration process much easier.

Security issues for medical data

The medical field involves huge amounts of information, which involves, inter alia, patient medical records, and personal information. The last several years have demonstrated that this information is a piece of the cake that appeals to malicious attackers. Ransomware and shady IT are just some of the issues confronting the medical sector, and the significance of protecting data in medical care is now in the spotlight. An antivirus software of a high standard should cope with all these issues. Read the TotalAV review to know more.

A survey conducted by the Ponemon Institute revealed that almost 90% of institutions in the medical industry have experienced a security leak in the past two years, and almost half of them, or 45%, have experienced over five security leaks in those two years. Assessments resulting from this research indicate that, on average, the cumulative value of a healthcare data problem is up to $6.2 billion. 

The main issue points for the healthcare sector that participated in the research were staff malpractice or inaccuracy, cyber-attacks, and the usage of unsafe mobile equipment. Other causes of leaks were third-party errors, harmful insiders, and stealing.

Basic criteria for information security

The FDA’s “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” guidance describes the US regulator’s basic approaches for assessing medical devices that use software or are connected to the Internet.

The FDA guidelines are based on four basic concepts: organizational processes, a risk-based approach, reliability, and secure operations. Each framework includes specific information security criteria for medical devices and defines the manufacturer’s approach to key aspects of cybersecurity:

  1. Organizational processes

This concept is related to the management of the organization. Management must ensure that the company’s focus is on information security. The cybersecurity responsibilities of managers must be documented in the relevant corporate documents. Specific individuals responsible for information security should be appointed.

The cybersecurity concept should become part of the Quality Management System and be embodied in standard operating procedures, instructions, and regulations. Mechanisms must be in place to ensure that the implementation of the prescriptions contained in these documents is monitored.

  1. Risk-based approach 

The FDA guidelines require manufacturers to integrate risk assessment and information management into the quality management system. The risk management system should cover the entire lifecycle of each product and take into account potential cyberattacks.

  1. Reliability

Software and programmable electronic systems must be assessed by the manufacturer in terms of potential vulnerabilities and weaknesses in the products. The manufacturer should take measures to ensure the reliability and resilience of electronic medical products.

  1. Safe operation

The manufacturer must conduct proper testing of its product to ensure that it operates safely in terms of information risks. FDA guidelines describe several potential methods to ensure the information security of a medical device.

Recommendations to reduce and manage cybersecurity threats

The exposure of medical equipment to hazards is increasing as these devices are becoming more and more plugged into hospital networks, the Internet, and other medical gadgets. Consequently, robust biosecurity is required to keep a medical product operational and protected.

In this regard, the FDA has created a guideline document to assist vendors in detecting cybersecurity problems that should be taken into account when planning and developing clinical products and getting them ready for the marketplace.

The FDA encourages vendors to incorporate cybersecurity hazards into the engineering and construction of healthcare appliances and submit documentation of the risks identified to the FDA. These vendors should also review the implementation of controls to help mitigate these threats. The policy document advises manufacturers on plans to offer operating system updates as well as fixes for OSs and medical software.

Security measures to be considered by device manufacturers

The FDA proposes the next security precautions that should be examined by medical equipment manufacturers to prevent unauthorized access cases:

  • Authentication should be employed to restrict access to medical equipment to authorized individuals. Different authentication techniques can be applied, such as username and password, biometrics, smart card, or multi-level authentication.

  •  Ensure that information is transmitted to and from the medical device in a secure manner using encryption where possible.

  • Introduce features that enable analysts to identify, locate, time, and take action on any security breaches.

  • Giving end-users relevant action information when a cybersecurity event is discovered.