As a life sciences pharmaceutical or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from hackers and others. 


Given the inter connectivity of corporate data networks, it has become all too easy for cyber thieves to gain access to valuable information in your network, and monetize your hardearned intellectual property (IP) or cause your company reputational or financial harms.


With the increasing integration of wireless, Internet and network- connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device related health information, the need for robust cyber securitycontrols to ensure medical device safety and effectiveness has become more important. In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact.


Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. 


Such cyber attacks and exploits may lead to patient  harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.  Increased connectivity has resulted in individual devices operating as single elements of larger medical device systems.

 

These systems can include health care facility networks, other devices,  and software update servers, among other interconnected components. 


Consequently, without adequate cybersecurity considerations across all aspects of these systems, a cybersecurity threat can compromise the safety and/or effectiveness of a device by compromising the functionality of any asset in the system.


The Guidelines are focused in discussing the importance of protecting vulnerable IP assets in cyberspace. It takes a look at the legislative landscape.


After that, there is a discussion of practical policies and procedures which companies can implement to help avoid loss and comply with regulations. 


FDA guidance is applicable to devices that contain software (including firmware)  or programmable logic, as well as software as a medical device (SaMD).


The guidance describes recommendations regarding the cybersecurity information to be submitted.