by Sylvia Norman, PhD, PMP
The Potential
We've all heard about wireless wearable devices that help you track physical activity, eating habits, sleep patterns and weight. Useful tools indeed. More recently though, wireless tech has broadened its focus to include the healthcare market. New digital health devices are being developed that help diagnose disease onset, monitor chronic diseases and improve quality of life for disabled and aging populations.
Here are some of my recent favorites:
The FingerReader - a team at MIT is developing this wearable audio device to help visually impaired individuals read printed or electronic text.
Google Diabetes Contacts - a contact lens being developed by Google and Swiss pharmaceutical company Novartis that will track glucose levels in diabetics.
PEEK Vision iPhone app - brings the ability to diagnose vision impairment to developing countries. This smartphone app scans for visual acuity and can be used to diagnose glaucoma, macular degeneration and cataracts.
The Lively Sensor - San Francisco based Aging 2.0 works with other companies to develop tech products for the elderly. The Lively sensor will help family caregivers remotely monitor whether an elderly parent has taken their daily medication and performed other important tasks.
A Digital Health Forum at the recent 2014 BIO International Convention highlighted the vast market potential for digital healthcare. Panelists discussed benefits like increased patient access to healthcare, decreased medical cost, increased patient engagement, improved chronic disease management and disease prevention.
The Challenges
The panelists also pointed out that this promising technology brings it's own set of challenges. Our healthcare reimbursement system, FDA regulatory policies, patient data management infrastructure and patient privacy policies are not ready for digital health. These factors combine to have a negative impact on both digital health innovation and the willingness of health providers to use new digital health technology. A recent blog article by Jean-Luc Neptune, MD provides an informative assessment of current roadblocks to digital health innovation.
The Future
The convergence of tech and biotech to develop new digital health products has enormous potential to improve the healthcare industry for both patients and providers. Yes, there are many challenges ahead, but dialogues to address them are in progress. For example, possible alternative reimbursement models are being discussed. In June 2014 the FDA released draft guidance to decrease regulation of medical device data systems (MDDS). The FDA stated it "recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data." At a recent local regulatory event, Dr. Camille Nebekker, Division of Behavioral Medicine UCSD, discussed the ethical and regulatory challenges presented by digital health. She is currently working with IRB boards to help define and mitigate unique privacy issues for subjects enrolled in clinical trials utilizing digital technology.
It's an exciting time for digital technology and healthcare. The convergence of these industries brings many new innovations and many challenges. Going forward let's remember this quote from Winston Churchill "the pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty."
Dr. Sylvia Norman is the Founder and Principal Consultant at Molecular Diagnostics Consulting.
Molecular Diagnostics Consulting Website
Molecular Diagnostics Consulting LinkedIn Company Page
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