Meaningful use is using certified electronic health record (EHR) technology to: Improve quality, safety, efficiency, and reduce health disparities. Engage patients and family. Improve care coordination, and population and public health.

Usability, Accessibility and Telehealth

A while ago there were two healthcare conferences that we attended here in Washington DC on the same day. One was the American Telehealth Association’s Fall forum and the other was The Interagency Committee on Disability Research (ICDR)’s Accessibility and Usability in Health Information Technology (HIT)

Crash test dummies and The Usability of Electronic Health Records

The big business interests of the Healthcare industry cried wolf (and lobbied hard)

against the meaningful use (now called “Promoting Interoperability”) program and enhancements to the usability requirements. Perhaps because they don’t want to spend the extra time and money to provide a healthcare system that truly follows a safety-enhanced design philosophy.

Most mHealth App Users Say Apps Improve Quality of Life

The majority of mobile health application users and medical professionals believe that mobile health apps are beneficial to their quality of life, according to a survey by Research Now, mHealth Intelligence reports.

Survey Findings

For the survey, researchers polled 1,000 mobile health app users and 500 medical professionals.

Overall, the survey found that 96% of surveyed mobile health users and medical professionals said that mobile health apps "improve their quality of life."

Among mobile health app users, the survey found:

  • 60% use apps to monitor activity/workouts (Gruessner, mHealth Intelligence, 6/12);
  • 53% use apps as motivation to exercise;
  • 49% use apps to record calorie intake; and
  • 42% use apps to monitor weight loss (Research Now survey, June 2015). 

Among surveyed health care professionals, the survey showed:

  • 86% knowledge believe mobile health apps will increase their of their patients' medical conditions;
  • 76% believe the apps will help patients with chronic disease management (mHealth Intelligence, 6/12);
  • 61% believe the apps will help those who are at a high risk of developing health issues;
  • 55% believe the apps could help healthy individuals stay healthy;
  • 48% believe the apps could help patients recently discharged from a hospital; and
  • 46% believe the apps will improve their relationship with their patients.

In addition, the survey found that just 16% of health care professionals reported that they currently use mobile health apps. However, 46% said they plan on using such apps in the next five years (Research Now survey, June 2015).   

Source: iHealthBeat, Monday, June 15, 2015

FDA Taking 'Very Light Touch' To Overseeing mHealth Apps

Bakul Patel, associate director for digital health at FDA's Center for Devices and Radiological Health, in an interview said the agency plans to take a light approach to regulating most mobile health applications, Bloomberg reports (Satariano, Bloomberg, 3/30).


FDA in February issued final guidance stating that it plans to regulate mobile health apps based on functionality, rather than their sale.

Specifically, FDA oversight will apply to apps that perform medical device functions and are therefore mobile medical apps. For example, FDA would regulate apps that:

  • Analyze patient data from a connected device or are being used in active patient monitoring;
  • Connect to an existing device with the purpose of controlling its operation, function or energy source; or
  • Transform a mobile platform into a regulated medical device.

Meanwhile, FDA would take a "hands off" approach for apps that are not considered to have a medical function, such as those used to:

  • Automate simple tasks for providers;
  • Interact with providers via electronic health record systems;
  • Self-manage conditions, without offering specific treatment suggestions; and
  • Organize or track health information (iHealthBeat, 2/9).

Patel's Comments

Patel said that FDA would not "want to be engaged in" regulating a "technology that's going to motivate a person to stay healthy."

Specifically, Patel clarified that the agency is focused on the regulation of apps that attempt to mirror a medical device's functions, rather than apps that track certain health metrics, such as heart rate or steps taken.

Patel also said that product marketing would play a role in whether FDA would seek to regulate a product. For example, he said that an app that claims it can help physicians to make medical decisions would warrant additional FDA scrutiny, as would products that are intended to offer treatment recommendations or diagnose diseases.

Patel added that companies with devices that host apps, such as Google and Apple, should contribute to ensuring that health apps accurately state their potential benefits.

Stakeholders Weigh In

Rock Health Managing Director Malay Gandhi questioned whether FDA and other federal agencies have the necessary staff and funding to adequately oversee the mobile health industry. He said, "We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren't."

Similarly, Derek Newell, CEO of health care startup Jiff, said that "FDA isn't built to handle new [product] categories" such as mobile apps and wearables. He said that it can take the agency awhile to be able to adequately regulate new product categories.

Further, some industry stakeholders, including Patel, have noted a disconnect between FDA and startup companies, which list FDA regulation as a main business risk.

To address the gap, Patel said the agency is looking to hire a new senior staff member to help improve relations with technology companies (Bloomberg, 3/30).

Source: iHealthBeat, Wednesday, April 1, 2015