Mobile health is an emerging area where we hear about the increasing possibilities of reducing costs and achieving greater patient engagement. Right now, there are over 97,000 health and wellness mHealth apps, as the projected revenue for mHealth in 2017 is $26 billion. Additionally, 93% of physicians believe mHealth apps can improve patient health. However, with fitness apps, electronic health records and the of greater utilization of telemedicine, the question that many are asking is what is mobile health?
To date, there is no standardized definition of mobile health or mHealth as its generally referred to. Organizations like the World Health Organization (WHO) has previously referenced mHealth “as an area of electronic health and it is the provision of health services and information via mobile technologies such as mobile phones and Personal Digital Assistants,” while the NIH Consensus Group referred to mHealth as “the use of mobile and wireless devices to improve health outcomes, healthcare services and health research.”” Having no clear definition usually creates a wild west regulatory scheme.
Currently mobile health is overseen by three regulatory agencies:
FDA: The FDA’s position on mobile health is that is it “taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of ‘device’ and that: are intended to be used as an accessory to a regulated medical devices, or transform a mobile platform into a regulated medical device. For many mobile apps that meet the regulatory definition of a ‘device’ but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. The FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets.”
FCC: “The Federal Communications Commission (FCC) regulates interstate and international communications by radio, television, wire, satellite and cable. The agency’s jurisdiction extends to non-Federal users of spectrum in the 50 states, the District of Columbia and U.S. possessions. The FCC manages Radio Frequency (RF) communications to ensure that RF devices operate efficiently and without interference. In the healthcare area, the FCC authorizes a wide variety of RF-based medical devices including both implanted devices and patient monitoring devices. It also authorizes carriers whose networks are used by a wide variety of mobile devices to access, store or transmit health information, and it establishes technical rules used by Wi-Fi and other similar networks.”
FTC: The Federal Trade Commission (FTC) protects consumers from fraudulent, unfair or deceptive acts or business practices. “The Federal Trade Commission has created a new web based tool for developers of health related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps. The FTC developed the tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).
The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance will point the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA) and the Federal Food, Drug and Cosmetics Act (FD&C Act).
The guidance, which is maintained on the FTC’s website, links directly to each agency’s information about applicable laws. In addition, the FTC simultaneously released its own best practices guidance for compliance with the FTC Act, by building privacy and security into their apps.”
Where mHealth is concerned, it has focused on the claims companies have made about the effectiveness of their devices or apps. In late 2015 the FTC showed it becoming more aggressive in its oversight of mobile health that may cause confusion on who the lead regulator is in this field. The FTC settled with a California based app developer named Carrot Neurotechnology for $150,000. The company pledged that their Ultimeyes app improved visual acuity, but the FTC stated that the company’s “promoters did not have the scientific evidence to support their claims that the app could improve users’ vision. Health-related apps can offer benefits to consumers, but the FTC will not hesitate to act when health-related claims are not based on sound science.”
Why the FTC? This shows how there is a “wild west environment” that exists with no lead regulatory agency. There are many questions around why the FDA has remained silent. Some theories are that the FDA’s current regulatory structure has not caught up with a 21st century issue such as mobile health. Additionally, the FDA may not want to give the perception that it could stifle innovation. Whatever the case, we could get further clarity on who regulates mobile health with a new Administration.
On the legislative policy front Congress currently has a few bills on point.
- S. 1101 titled the Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act wants to exempt certain software that promotes healthy lifestyles from being classified as a medical device subject to FDA oversight.
- H.R. 2396 titled the SOFTWARE Act sponsored by Congresswoman Blackburn (R-TN) is now part of the 21st Century CURES legislation. This bill seeks to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components. Health software is exempted from FDA oversight except for software that provides patient-specific recommendations and poses a significant risk to patient safety.
- H.R. 5906 titled the Wi-Fi Capable Mobile Devices Act of 2016 directs the FCC to issue rules to ensure that providers of mobile broadband Internet access service supported through the Lifeline Assistance Program offer mobile devices that are capable of: (1) receiving Wi-Fi or other wireless broadband signals using unlicensed spectrum, and (2) sharing a mobile service connection with other compatible hardware or devices.
So, is mHealth something that specialty pharmacy can take advantage of? I believe so. First it would be best to be aware of some of the emerging mHealth technology to tell your patients as some approved products can have an immediate impact on their outcomes. For example, the Mount Sinai Health System in New York has launched an enterprise-wide platform for doctors to prescribe mobile health apps directly to patients. The platform called RxUniverse features a curated list of apps – pulled from the thousands of health apps available to consumers today – that have already been evaluated for their efficacy based on published literature. Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, which pairs with a smartphone and allows users to examine the ears, throat, skin, heart, lungs and temperature. Data will be captured, stored and shared via a cloud-based telehealth platform with video conferencing. Examinations can be done in real time or in advance of a telehealth visit.
A second suggestion is to be aware of the continued emergence of telemedicine. Telemedicine is an area that has been grouped in with mobile health and has shown strong signs of momentum on both the state and federal level as policymakers recognize that telemedicine will help rural patients achieve greater access. Besides expanding the benefits of telemedicine to patients outside of rural areas and the eventual sorting out of licensure concerns, the only major roadblock that exists here is how are providers that engage in telemedicine going to be reimbursed?
Lastly, mobile health can help specialty pharmacies increase medication adherence. Per the Network for Excellence in Health Innovation, medication non-adherence costs our system $290 billion annually. We have seen patients today that are not only more tech savvy in that they own smartphones, tablets and other connected devices, but these patients are the more engaged than ever in trying to improve their own outcomes. By developing or utilizing apps, adherence tools or how to videos, you can help your patients achieve their personal goals but they key is to make sure that these digital resources are simple to use and provides the necessary incentives to keep your patients engaged long term. Contact us today for more information.