FDA continues to be active in emphasizing the importance of artificial intelligence in health care. Now, FDA has committed to a program of creating a knowledgeable, sustainable, and agile data science workforce ready to review and approve devices based on artificial intelligence.

In April of last year, FDA Commissioner Scott Gottlieb, in discussing the transformation of FDA’s approach to digital health, stated that one of the most promising digital health tools is Artificial Intelligence (“AI”). Then, in September of 2018, the commissioner again referenced AI as one of the drivers of unparalleled period of innovation in manufacturing medical devices. And, we saw FDA approve a record number of AI devices in 2018. We have discussed this here and here.

On January 28, 2019, Gottlieb announced that Information Exchange and Data Transformation (INFORMED), an incubator for collaborative oncology regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of the public health, is going to be working with FDA’s medical product centers. Together, they will develop an FDA curriculum on machine learning and artificial intelligence, in partnership with external academic partners.

INFORMED was founded upon expanding organizational and technical infrastructure for big data analytics and examining modern approaches in evidence generation to support regulatory decisions. One of its missions is to identify opportunities for machine learning and artificial intelligence to improve existing regulatory decision-making. So, it makes sense for FDA to use this already existing incubator (although oncology focused) to facilitate increasing knowledge across all of its centers. While it is unclear what the curriculum will look like and who the “academic partners” are, the announcement by FDA that they are seeking the assistance of outside consultants and committing to training its personnel in anticipation of the growth of AI in health care is an important advancement for all those engaged in the development of AI-based devices.

Apple was recently granted a patent (10,189,434) for an augmented safety restraint. Say that again? Yes, with the rise of autonomous vehicles comes the need for changes in the safety devices placed within these vehicles. If you are wondering why this is an important patent, you are probably not alone. Currently, the states that have addressed the use of autonomous vehicles have done so with little emphasis (if any) on the safety features within the vehicle, beyond requiring what is currently mandated under the federal regulations for non-autonomous vehicles.

So, what is different about Apple’s augmented safety restraint ? The patent provides that the restraint, beyond securing the passenger within the vehicle, can

  • provide holistic monitoring of passenger status;
  • supply entertainment and comfort;
  • allow communication or interaction between the passenger, vehicle, and other passengers within the vehicle; and
  • generate power sufficient to run the aforementioned capabilities.

The reason for all of these features is to “allow for enhancement of passenger activities, improved interaction with the vehicle and/or other passengers, and energetic autonomy while at the same time meeting regulatory safety requirements.”

In order to perform the above, the device(s) will be attached to an exposed surface or embedded within the restraint. The suggested devices include contact sensitive features, such that the passenger would need to touch the device for engagement (example: a fingerprint sensor) and non-contact sensitive features (example: optical or voice-activated sensor).

In addition to the common three-point seat belts, other restraint types (e.g., inflatable belts, webs, harnesses, etc.) are noted as being possible designs for the augmented restraints. Some of the proposed features are even proposed to be activated either with or without a passenger present in the vehicles (such as devices to help aid passenger ingress or when the vehicle is transporting only packages).

In what appears to be an effect to maintain compliance within current safety standards in place, the restraints may also include an airbag and any or all of the augmented safety restraints can include a pre-tensioner device. The restraints have a passenger-securing structure, for example, a belt or a harness secured to either the vehicle or the passenger seat.  There is also a passenger-facing surface that can engage the body of the passenger to restrain motion of the passenger relative their respective seat.

Apple’s patent suggests numerous iterations of how the augmented safety restraint can look and work. How these iterations affect the safety of a vehicle have yet to be determined. Without any guidance, manufacturers are left creating designs for standards that may not apply to autonomous vehicles or standards that have yet to be created.  As the federal government continues to fail to pass any legislation regarding autonomous vehicles, this may be yet another area in which states will need to act on their own while autonomous vehicles proliferate on our roadways.