- The mHealth market is making a big splash in the healthcare industry, as more individuals are using wearables, mobile apps, remote monitoring tools, and telehealth technology to maintain their health and wellness throughout their life. This large market impacts a large sect of this country’s population, which means mobile health regulations remain a priority of stakeholders and healthcare providers as well as the public sector.
A few years ago, the Food and Drug Administration (FDA) began adopting more mobile health regulations and developing greater oversight over this new market, according to a report from pwc. Many nations are creating more aggressive policies against mobile health despite the fact that mobile health apps could be non-intrusive and not as dangerous as issues of other medical devices.
The report also discusses how telecommunication requirements are also often similar to mobile health regulations, which may be erroneous since phone manufacturers and network operators have different risks associated with their applications from mHealth developers.
Interoperability is a major part of ongoing regulatory requirements among the health IT field with the Office of the National Coordinator for Health IT (ONC) looking to prevent information blocking and improve interoperability among EHR systems. The mobile health field will also play a role in improving interoperability and connectivity between different data sharing devices and mobile health apps.
Along with interoperability, mobile health regulations will need to focus on patient data security and privacy in order to keep patients’ identities safe and protected from data breaches or HIPAA violations.
Some past mobile health regulations the Obama administration moved forward include the Food and Drug Administration Safety and Innovation Act (FDASIA), which President Obama signed on July 9, 2012.
This particular legislation allows the FDA to keep creating mobile health regulations as well as speed up the process of approving mHealth devices and apps. At the end of 2012, Representative Mike Honda (D-CA) brought forward a new bill that would offer more assistance to entrepreneurs and mobile health app developers.
“Representative Mike Honda (D-CA) introduced the “Healthcare Innovation and Marketplace Technologies Act” (“HIMTA” H.R. 6626) on 3 December, 2012 in the 112th Congress to clarify existing regulations and provide support for entrepreneurs. The bill would establish an mHealth developer support program at the Department of Health and Human Services to help mobile application developers build their devices in compliance with current privacy regulations. It would also establish a national hotline, an educational website and an annual report that would translate privacy guidelines into common English,” the pwc report stated.
Essentially, the new technologies available within the healthcare industry including the mobile health field is bringing forward a changing regulatory landscape, which medical providers will need to navigate in order to successfully improve patient care and health outcomes.
There are specific steps that mobile app manufacturers can follow when developing mHealth products and following regulatory practices. These include making sure the product benefits physicians and hospital infrastructure, developing an easy-to-use solution, creating a reimbursement model, and ensuring that the new product works well with current technology platforms already established within a hospital or clinic. It is also important to remember how mobile health technology can affect patient engagement throughout the healthcare field.
“Cell phones and other consumer digital technologies have emerged as potentially powerful tools to engage patients in health care. They can strengthen the efficacy of safety-net health systems by improving providers’ capacity to reach vulnerable populations and actively engage them in their care. In the United States, minority and low-income people have a high level of cell phone adoption, and often use features such as text messaging and mobile Internet. Mobile health interventions frequently involve the use of text messaging to provide concise, timely, and customized care-related information in the form of reminders and motivational and educational messages. These notifications can promote self-management practices for chronic conditions, educate consumers about preventive care and personal wellness, and improve patients’ adherence with recommended treatment,” The Commonwealth Fund reported.