Important Updates on COVID-19

As the COVID-19 (coronavirus) pandemic continues to evolve around the world, Otsuka stands united with our global community to navigate this fast moving and complex healthcare event.

Read the full statement

Ethics by Design: Digital Health Data Collection

Innes MeldrumVice President, CNS Marketing and Sales

As Vice President of the CNS & Cardio-Renal Marketing organization at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for leading our Marketing and Sales teams to create, execute, and innovative differentiated marketing strategies and tactics. I also have responsibility for commercialization of our CNS & Cardio-Renal pipelines. I have more than 20 years of experience in executive strategic, marketing, sales and business operations in both the pharmaceutical and technology industries.

Ethics by Design: Digital Health Data Collection We are living in the midst of a healthcare revolution. Today, more than 165,000 mobile health apps are available through Google Play and Apple Store.  Numerous organizations including IBM Watson and Cloudvara, are exploring how to apply artificial intelligence to make sense of the data collected.  Such insights, over time, could lead to new treatment approaches, medications, or medical devices. Through sensors, tracking devices, and other data-collection tools, we have the ability to identify trends, anomalies, or other environmental or physical factors that could affect how we treat and manage disease – and ultimately, enhance people’s lives. But with that promise comes enormous responsibility.  The ability to collect personal data brings with it the need to ensure such data is properly collected, stored, analyzed and shared to protect the privacy and security of the individuals.This is unchartered territory for those of us working in healthcare.  To help navigate this new land, we need new perspectives and new ways of thinking about the patient experience and how to ensure personal information is handled appropriately.Otsuka knows this first-hand. Last year, we were excited to become the first company to gain U.S. Food and Drug Administration approval of a digital medicine system that combines a medication with a sensor to track medication ingestion and collect pertinent data: Click here to learn more.Given that we would be collecting, storing, and managing data related to patients with serious mental illness, we recognized that the development process wasn’t going to follow a traditional pathway.  We knew we needed to take a deep dive to understand this technology, and to ensure that it would not have an impact on the privacy of our patients.  We wanted different points of view and opinions.  We wanted to make sure everything we did was in compliance with current laws, but also in alignment with ethical principles. Our solution was to create a steering committee of bioethicists to help us design the product with a patient experience that would respect the privacy of the data collected.  Starting with an advisory board consisting of 12 highly credentialed bioethics thought leaders in the traditional and emerging digital spaces, we identified four individuals to serve as independent bioethics consultants, including: 
  • Jack Schwartz, J.D., who focuses on Bioethics and Health Law at Yale Law School
  • Glenn Cohen, J.D., who focuses on health information technologies, mobile health, and health policy at Harvard Law School
  • Laura Dunn, M.D., who specializes in informed consent and decision-making capacity at the University of California
  • Craig Klugman, Ph.D., who specializes in Public Health Ethics, Ethics Education, and End of Life Issues at the University of Texas
These experts helped us to not only identify the relevant considerations with regards to privacy and data security, but also to identify the critical issues and the options for addressing them, and to weigh the ethical considerations from all sides. The result was the establishment of an “ethics by design” framework to guide our work and that encompassed a set of key principles that any effort involving health data should take into consideration.  These principles included:
  • Autonomy: every patient should have the right to express personal decisions free of outside interference and to have these decisions honored.
  • Beneficence: any project should make an effort to maximize the help given to patients.
  • Non-maleficence: any project should make a concerted effort to minimize potential harm.
  • Justice: initiatives should be fair and treat people equally and without prejudice while distributing benefits and burdens equitably.
Using these guiding principles, our product development team ensured that careful ethical decisions were included in the product development process.This framework was integral to our process and helped us understand the implications of considerations such as how data would be collected, who would own the data, how to protect the data, and the process for obtaining informed consent. The following are just a few of the patient-specific issues addressed in the course of this process:
  • Informed Consent: creating a “User Agreement” as part of the informed consent process
  • Patient Understanding of Provider Monitoring: creating clear language to explain what information will be shared
  • Data Management: clarifying how data is stored, de-identified and de-aggregated, withdrawn, and used, and clearly indicating who owns the data and how it can be used in the future
  • Fair Distribution: examining how to ensure different people, from different income levels, can get access to technology
As I worked with the group, it became clear to me how important it is to create a new discipline and skill-set focused on the ethics of digital medicines. Never before have we had the ability to collect so much personal information from individuals that if applied appropriately could have such a huge impact on their lives.  To apply that information appropriately we need to create a new skill-set and inform and educate those who are responsible for managing such personal information.This goes beyond simply gaining advice and counsel from experts.  It demands taking that knowledge and encouraging people within our organizations to question, probe, and look for the right solutions. The bioethicist panel was just a first step in creating this new discipline for healthcare.  As we continue to look for new ways to apply technology and data to improve health outcomes, our industry will have to examine these and other complex issues continuously.  We’ve learned a lot through the process, and my hope is that others in our industry can benefit from our experience.April 2018          01US18EUC0067
Back to blogs
Back to blogs

Add a Comment

Sign in with

  • Or

    Sign in with

  • We will only use your email address for verification purposes