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IP Strategies for Digital Health Products and Services: What Can You Protect in a Data-Driven World?

Author: Maia H. Harris

8/23/2016
IP Strategies for Digital Health Products and Services: What Can You Protect in a Data-Driven World?

This article was published on August 23, 2016 on IPWatchdog. Excerpt printed below with permission.

EXCERPT: Consider this: You learned in your monthly meeting that your R&D group has developed ThinSensor, a wearable sensor that can measure glucose levels at programmable intervals, will transmit high/low glucose alerts in real time by text or email to any group of individuals identified by the user to receive them, and will otherwise store the collected data and the time it was taken in a database that is accessible by the sensor wearer and any of her caregivers and medical professionals via a web-based application either on a mobile device or computer. Any individual with access to the application, including doctors and medical professionals, can also input additional information about the sensor wearer, including notes about medications and any related adverse events, doctor’s visits, weight, daily exercise and diet.

But there’s more! Work on ThinSensor2 is already underway, and the plan is to include additional sensing and data collection functionality, ranging from protein and cholesterol tests to pulse rates and step counts. In addition to storing this data and making it available in the same manner and to the same individuals as the original ThinSensor system, the intent is to combine all the collected data with two additional data sets licensed from third parties: The first is a more generalized historical patient data set from a larger population, and the second is a database of academic and clinical research publications.

Once combined, the group plans to enter a joint development agreement with another third party to further utilize the integrated data sets to develop predictive analytical tools that will be incorporated into a third version, ThinSensorU (for “ultimate,” of course). This is the golden child of the R&D pipeline — it will be equipped with text, email and video communication systems that will alert users and their caregivers of medical issues that may arise up to six hours in the future, and it will provide access to a medical professional to discuss whether immediate action should be taken based on a report that is automatically created as part of the alert system.

Certain elements of this project plan likely sound familiar — wearable sensors with data collection capabilities are already on the market, and not just for monitoring glucose. The remainder of the TrueSensor pipeline plan is not so far-fetched, either — TrueSensor, and projects like it, are at the rapidly developing intersection of health care IT, medical devices and pharmaceutical products. Indeed, the promise of using digital health and precision medicine to lower health care costs and obtain better patient outcomes surprisingly seems to be both imminent and the subject of science fiction.

Disruptive innovation, like what we are seeing in the health care industry, often causes disruption elsewhere, and the legal landscape is no exception. The life cycle of digital health products and services — from conception to promotion — presents a unique set of legal challenges, and there is no one-size-fits-all approach to the matrix of issues facing these products. As a lawyer, these are the kind of projects that remind us of law school exams — lots of issues and, often, no clearly defined answers or solutions.

True to form, the hypothetical ThinSensor product line raises myriad pre- and post-launch regulatory, privacy, security and promotional issues. An analysis of those issues is beyond the scope of this article.[1] Instead, we will focus on the issues facing the ThinSensor management team in a rapidly changing intellectual property environment. One of their jobs is to maximize protection of the ThinSensor system’s market position with the IP tools they have at their disposal: patents, copyrights, trade dress, trade secrets and best practices for contracts and licensing. This article explores some of those tools and why one might choose to pursue one or, in the more probable case, some combination of them.

Full article available at http://www.ipwatchdog.com/2016/08/23/ip-strategies-digital-health-products-services/id=72111/.

The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.