News Updates

New technology and the incredible amounts of data that is and will be generated from various digital health applications and innovations has the potential to change how companies conduct research, clinical trials, patient studies, house medical records and how doctors treat patients, especially those suffering from chronic conditions.

While most experts agree that the three main benefits of mobile and digital health are increased patient engagement, increased adherence and assistance with clinical trial management, the industry also acknowledges that many challenges abound, especially related to data analytics, use, privacy and evolving regulation.

Consumer Interest

The following data from eMedCert illustrates the current level of interest and demand in wearables by consumers:

• The annual smart-wearable health care market volume will grow from $2 billion in 2014 to $41 billion in 2020, a compound annual growth rate of 65 percent.
• Over 80 percent of consumers said an important benefit of wearable tech is its potential to make health care more convenient.
• 68 percent of consumers would wear employer-provided wearables streaming anonymous data to an information pool in exchange for lower health insurance costs.
• Today, one in five Americans owns some type of wearable technology.

Additionally, mobile health app companies invested about $220 million during Q1 of 2015 — further supporting the popularity of health apps to manage chronic conditions and other illnesses.

FDA Regulation and Industry Challenges

As not all wearables are created equal, the Food and Drug Administration (FDA) has taken steps to address the differences in devices. The agency will regulate any device that makes specific claims about treating a recognized disease or medical condition, such as diabetes. Currently, the most popular uses for wearables are for pulmonary conditions, diabetes, heart disease and clinical trials.

According to the draft guidelines issued by the FDA, a wellness product crosses into the territory of a medical device when its intended use refers to a specific disease or condition, or it presents an inherent risk to a user’s safety. Given the number of devices that are in pilot or launch mode, and as technology often outpaces regulation, developers, providers, payers and life sciences companies will have to keep an eye on evolving regulation.

Data Analytics

In addition to compliance challenges, developers, health care providers, payers and life sciences companies and their partners must also figure out how best to utilize the data from these devices, while ensuring patient privacy and data security.

Just as FDA regulations don’t apply to all wearable devices, the Health Insurance Portability and Accountability Act (HIPAA) doesn’t apply to most of the information that can be harnessed from health wearables. However, if doctors are using the data for treatment of chronic diseases, life sciences companies and their partners, which are downloading, storing and analyzing the data, must wrestle with the implications of using that data in violation of HIPAA.

Specifically, in order to comply with HIPAA, companies must only analyze health data within the confines of what is permissible under the law. Any other non-medical data must be kept separate to ensure further privacy. As patients have to opt into data collection as part of a treatment using a health wearable device, companies must offer complete transparency into how the data will be used. Since health care and life sciences organizations increasingly store data information on the cloud, they must take greater steps to secure patient data to avoid HIPAA violations and protect the information using access controls and encryption. These measures make companies more accountable to patients and can alleviate concerns patients may have about sharing private health information.

Role of Partners

An expert partner can provide multi-channel engagement solutions to life sciences companies, payers, and health care providers to greatly increase user and adherence rates and improve patient outcomes, while addressing some of the most common challenges related to wearables.

These types of companies provide end-to-end solutions that include kitting and configuration, distribution, training, help desk services and most importantly — adherence and condition management support. The latter not only helps increase engagement and usability, but also provides life sciences companies, payers and providers with the necessary data to address disease management and related problems. Additionally, these partner companies can provide remote monitoring, provide disease prevention and risk identification and personalized treatment at scale.

Trends and the Future of Wearables

Because the health care landscape is so complex and the patient consumer and their needs so diverse, many experts agree that we are still many years away from realizing the full potential of digital health. As consumers continue to see more benefits and companies prove and understand all they can achieve as a result of the data derived from these devices — mass usage will become the norm.

According to IDC Health Insights, by 2018, 70 percent of health care organizations worldwide will invest in consumer-facing technology, including apps, wearables, remote monitoring and virtual care. According to CDW Healthcare, wearable technology could drop hospital costs by as much as 16 percent over the course of five years, and remote patient monitoring technologies could save the health care system $200 billion over the next 25 years.

Additionally, innovative mobile health technology has the great potential to decrease health care costs due their ability to efficiently monitor and influence patient health. As applications become more prevalent — especially if prescribed to them by their doctors or paid for by their health insurance companies — consumer use will grow, thereby increasing adherence, decreasing hospital readmission rates and enabling consumers to see immediate health benefits. With a shift to value-based health care, doctors will prescribe more devices as part of the treatment plan, giving way to platforms and ecosystems that support users of multiple wearables, devices and apps as well as organized data and visualization tools. It’s clear that the new era of preventive medicine is here and with it a system of health care that a decade ago didn’t seem possible.

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This article originally appeared in the February 2016 Global Forum.