To ensure optimum benefits from medical devices, industries must apply the best practices for medical device cyber security. Let us detail each of these tips below.
Best Practices for Medical Device Cyber Security
1. Standards for suppliers
Any vendor or supplier who is contracted to supply medical devices must meet the following conditions:
- Cyber Security Program: This program must be in place and an active part of the organization.
- Auditing: The organization must employ third-party auditors to audit its cyber security program to ensure compliance with the Program.
- Training: The organization must provide training for its employees involved in the design, manufacture, or servicing of medical devices to ensure knowledge of cyber security best practices.
- Penalties for Policy Violations: Any breach in the Policy must have a corresponding punishment that is sufficient to discourage any other violations in the future.
- Privacy Impact Assessment: Every organization in the medical device design, manufacture, or servicing must conduct a Privacy Impact Assessment (PIA). By doing so, you can determine how the use and access of information about patients by unauthorized persons. This PIA should be updated at least once every year, and if any risks are identified during the process of PIA, appropriate security measures should be taken
2. Cyber security team members
The cyber security team within an organization that is involved with medical device design, manufacture, or service should have enough members to ensure efficient productivity. This may range from 6-15 members depending on the size of the organization.
In addition, each member should have specific roles and responsibilities assigned to them based on their expertise and experience level. This team should also have a manager who is responsible for overseeing their work, ensuring that they are meeting all deadlines, budgets, and other expectations set by senior management.
3. Following the ISO/IEC 15408 Standards
Medical device manufacturers in any country should follow ISO/IEC 15408 standards at all times. Most especially, when developing new products or making changes in existing products.
This ensures adherence to cyber security best practices in this domain and helps companies reap maximum benefits from their products while keeping patient data secure at all times.
4. Ensure IT Protection at All Times
All organizations that are into medical device design, manufacture, or servicing should take all necessary steps to ensure that their Information Technology (IT) networks are secure at all times.
For example, this includes using firewalls, IDS/IPS systems, anti-virus software, data backups, encryption practices, etc., which are all well-known aspects of cyber security best practices for this industry sector.
5. Proper Segregation of IT Networks
All organizations in medical device design, manufacture, or servicing should segregate their IT networks into different zones. Depending on the classification of data that is transmitted across them. This will help prevent sensitive data from leaking into the wrong hands and potentially harming patients.
6. Employees Should Have Training
All organizations should ensure that all employees undergo cyber security training at least once every year. Customize the training material. For instance, according to the role of each employee and their responsibilities within the organization.
This helps ensure that each employee can understand and follow cyber security best practices in their day-to-day work.
7. Regular Audits
All organizations should conduct regular audits of their IT systems to ensure that they are working as intended and meeting all regulatory requirements at all times.
This is important as it helps organizations ensure that it is meeting industry cyber security best practices and also helps them maintain a healthy network environment.
