Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing devices that will be networked.
- Use a firewall and periodically maintain its configuration
- Change those vendor supplied defaults for usernames, passwords, identifiers, etc.
- Encrypt data at-rest and in transport. It’s just too easy to always protect data. Just do it.
- Use anti-virus software on development systems, test systems, and other systems that “touch” the product
- Install vendor supplied security patches
- Limit access to data – de-identify data early in the process.
- Obviously, use unique IDs for authentication and add something that is not obvious, e.g., 4 digit number added to first name and last name
- Restrict access to physical locations where data is retained
- Manage users, both incoming and termination, and monitor activity
- Periodically test security layers and re-assess acceptability
- Create policy in addition to procedure for security expectations for employees and sub-contractors
- Any cybersecurity expectations of our customers/users should be clearly communicated in product labeling
FDA has provided two guidance documents (find them on our Popular Resources page) and there are standards and technical reports that can be helpful as well. Here are a few that we recommend:
- AAMI TIR57: Principles for medical device security—Risk management
- UL 2900-1 Cybersecurity Standard for Medical Devices
- ISO 27799:2016 Health informatics — Information security management in health using ISO/IEC 27002
Our partner Sherman Eagles provides periodic updates on standards and technical reports affecting medical device systems and software, and also provides a unique, one-of-a-kind concierge-level mentoring. See our subscription options to start receiving Sherman’s updates today and engage with Sherman to raise your quality system bar!
