Tell us about your background and how you came to work in this field. What interested you about EP?
I was a board-certified practicing cardiac electrophysiologist for 20 years (Director, Cardiac EP at Pinnacle Health System, Harrisburg, PA) and one of the very first adopters of remote patient monitoring (Medtronic CareLink) over 11 years ago. My interest in wireless health technologies then expanded when I incorporated some of our practice’s monitoring capabilities with the electronic medical record system in 2004-2005. Following this, my interests in the expanding world of remote patient monitoring, sensor technology development, and the field of digital health led me to leave practice and pursue a career in full-time consulting in the field. Digital and wireless health technologies will be the game changer of healthcare in the future, and I wanted to be there in its infancy, just as I was in the early years of EP.
Describe your work with DLS Healthcare Consulting, LLC.
The company is focused on advising wireless health technology companies in various areas, with a unique clinical perspective. Experiences in medical device consulting, clinical investigation, regulatory oversight, and reimbursement are leveraged in our assistance along the life cycle of technology and business development. The importance of clinical workflow involved in the design and implementation processes are stressed, as human factor assessment perspectives are often overlooked. The bulk of our work is with helping hospitals adopt wireless technologies to benefit operations, patients, and providers, as well as partnering smaller mobile health companies with medical device companies which are looking to enter the mHealth market.
Tell us about your experience using Twitter. For example, when did you create the Twitter feed, and why?
The ever-increasing role of Twitter as a business development innovation tool is clear. It provides a vast amount of healthcare industry information and is a source of data from bloggers, regulatory agencies, analysts, pharmaceutical and device companies, professional organizations, and providers. I created my Twitter account the day I started the company. This has been, by far, the biggest driver of business for me. I both provide and receive vast amounts of professional information via Twitter daily. It is how I start my day. I no longer read newspapers. Customized RSS feeds, links from my network of colleagues, and other trusted sources provide more in-depth information and exchanges in a focused, unparalleled manner. I look at Facebook as a social club or bar, and Twitter as a customized business ticker tape. I interface other tools such as LinkedIn with my Twitter feed. The intersection of multiple social media sites affords a critical opportunity in today’s business world.
What are some of the current challenges or issues in digital health technology?
The beginning of the digital health age is here. A great overview of this is described in a recently published book by Eric Topol, MD, entitled The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare. The challenges are those common to any major shift in healthcare, of which this will be the greatest in history. The FDA has recently proposed and will soon finalize rulings on its oversight of mobile medical applications. There is a mobile health app certification process underway. There are bills in Congress regarding national licensure of physicians in telehealth. Another big challenge is wireless security. Providers with their own mobile devices (the BYOD, or ‘bring your own device’ scenario) in a hospital present a significant risk. Recently, The West Wireless Health Institute released a small cell architecture which is uniquely designed for this purpose, and is offering it free to hospitals. Venture capital money in the medical device industry has been tight lately, but companies in the telecomm, insurance, consulting, and medical device industries are heavily investing in the sector. There are also a few mHealth incubator investment companies encouraging startups. The CMS itself has grants over $1B to encourage innovative technology adoption in healthcare. Reimbursement issues are being addressed as well, and will not be a problem as CMS and payers are fully behind mobile health initiatives. The process, however, as with all political processes, will take some time. The UK has recently stated that it will encourage incorporation of mobile health technologies to be adopted by providers.
What are your thoughts on whether cardiac patients should have access to their own cardiac data?
I have recently made this topic a focus of my blog and Twitter communications. It has received a huge following in both social and maintstream media. I was also interviewed by NPR, which is doing a feature story on the subject. As a practitioner, I gave my patients their ICD data. Obviously patients have no need for nor would understand a complete interrogation of their implantable device. However, things like lower ICD rate limits, pacing rates, device battery longevity, and significant arrhythmia events are things they or their caregivers should be aware of. The Heart Rhythm Society’s IT committee, of which I am a member, has been working for a while on a plan which will furnish patients, via their EHR patient portal (which will be part of the EHR included in Meaningful Use Stage 2), some pertinent data from their devices.
What involvement do you think the FDA should have in overseeing digital health technologies such as mobile health apps?
I think that the FDA should be involved in technologies or apps which diagnose or treat patients, or accessories which make a device one which diagnoses or treats. There are industry people who are arguing fervently that the FDA should not be involved. I recently wrote a rebuttal to a widely circulated article from that corner: http://davidleescher.com/2012/02/14/five-reasons-why-digital-health-technologies-need-fda-oversight/
What are the benefits of digital health technologies for the healthcare field?
They will transform a provider-centric system to one which is patient centric. Mobile technologies will provide patients with tools which will educate them as well as caregivers about health, diagnoses, treatment options, and disease management. Patients will have the ability to then take more responsibility and engage in their own healthcare. The monitoring tools will provide them with data derived from their own bodies. Many other sensor technologies are here or will be soon. Some examples are multisensor tools furnishing all vital signs, a smartphone case which provides single-channel, real-time digital ECG recording (AliveCor), shoe sensors to track gait disturbances, dissolvable sensors in pills signaling gastric absorption, and injectable nanosensors to detect specific diseases or blood chemistries. Patients will be able to be discharged home armed with wireless technologies which will monitor them better than visiting nurses or family members, with only actionable alerts sent to providers.
What advancements do you think we’ll see in the areas of remote patient monitoring and digital health technologies in the near future?
I believe that remote patient monitoring (RPM) has already proven to be the best way to follow patients with implantable devices. Post-market surveillance discovery of faulty ICD leads and rapid discovery of silent AF have already demonstrated the benefits of RPM over traditional follow up. The ultimate advancement will be the era of personalized medicine, whereby a rapid determination of a personal genome will dictate how best to keep a person well and how to optimally treat based on genetic factors.
Is there anything else you’d like to add?
I would like to see all data derived from RPM on a population level available to anyone. The data will be de-identified, and can be utilized on a public health scale to determine efficacy of devices, arrhythmia prevalence/geographical variances, and in many other research endeavors, which may ultimately result in benefits way beyond the devices themselves. Crowd-sourced data will benefit industry, public health initiatives, and better treatment for all patients. Recently, the American Board of Medical Specialties created a new specialty of Clinical Informatics. I am excited to be a part of the digital and mobile revolution of medicine.
David Lee Scher, MD is a former cardiologist and cardiac electrophysiologist, and owner/director at DLS HEALTHCARE CONSULTING, LLC, uniquely concentrating in advising digital health companies and their partnering institutions, providers, and businesses. A former cardiac electrophysiologist, clinical trial primary investigator, human subject research committee (IRB) chairman, Medicare advisory committee member, he is Board Certified in Internal Medicine, Cardiovascular diseases, and Clinical Cardiac Electrophysiology. A pioneer adopter of remote cardiac monitoring, he lectures worldwide promoting the benefits of digital health technologies. He can be reached at email@example.com, Twitter at dlschermd, and on LinkedIn at http://www.linkedin.com/pub/david-lee-scher-md/27/16a/90. Dr. Scher blogs at http://davidleescher.com. He was chosen as one of the ten cardiologists to follow on Twitter and one of the top ten bloggers about health care IT. For more information about DLS Healthcare Consulting, LLC, please visit digitalhealthconsultants.com