Request Demo
Request Demo

Earlier this year, the U.S. Food and Drug Administration (FDA) published final guidance articulating the difference between the “low-risk” digital health apps, devices for general health management, and those apps and devices that needed FDA 510(k) clearance.  In short, the FDA provided information on the kinds of apps and devices for which it will and will not take action.  Apps that assist in promoting or maintaining a healthy weight or with weight loss goals and healthy eating are not going to be subject to FDA approval.  However, apps that claim it will treat or diagnose obesity, an eating disorder, such as bulimia or anorexia, or an anxiety disorder will be subject to FDA scrutiny.  Since the FDA does not have the resources to screen the tens of thousands of digital health apps that are available in the market, the strategy to separate “low-risk” tools had to be done.

The FDA decision did not help employers that want to embrace digital health tools but also do not have the resources to identify appropriate technologies for their employees.  The good news is that Apple established rules for digital health companies aspiring to use the technology giant’s iOS network.  Below are some of the changes:

  • Apple will now have the ability to reject apps that have the potential to cause any physical harm.
  • Medication calculation or dosage apps must be developed by a drug manufacturer, hospital, university, health insurance company, or other approved entity, which means individuals cannot publish an app to manage medication dosage to the app store.
  • No more marijuana-related apps.
  • Apps that encourage people to place their iPhones under a mattress or pillow while charging (such as those that monitor sleep) will no longer be allowed.
  • If an app provides inaccurate data or information that could be used to diagnose or treat patients, it will get increased scrutiny.

With Apple’s iOS screening process having influence on the digital health community, their commitment to high quality digital health apps will be a boon for consumers globally, and as a result, employers will also be beneficiaries.  Employees will have less access to low quality and/or dangerous health technologies, and many of these app developers will likely have to shut their doors or improve their quality.  This will create more opportunities for higher quality tools and provide those companies with more resources to invest in their solutions.

Get our latest articles delivered straight to your inbox!

President Biden’s Updated COVID-19 Decrees – What Employers Should Know

In his speech last Thursday, September 9th, President Biden laid out his administration's updated...

Employers Respond To FDA Approval Of COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19...

CDC Guidance Released As Millions Of Adults Receive COVID-19 Vaccine

On March 8, the CDC released its first set of guidance for adults that have received the COVID-19...

Biden Administration Calls On Employers To Support COVID-19 Vaccination Efforts

Last month, the White House COVID Response Team gave a press briefing on the current state of the...

EEOC Issues Proposed Wellness Incentive Rules, Impacting Workplace Wellness Programs

This blog was written by a guest contributor, Barbara Zabawa, President of the Center for Health...

Experts Explain Details Surrounding Proposed EEOC Rule Changes

Following years of anticipation, the U.S. Equal Employment Opportunity Commission (EEOC) is finally...

With Reopening Plans Underway, Employers Shouldn’t Leave Out Benefits Changes

In May, due to the impact of the COVID-19 pandemic on business operations, the IRS issued a notice...

USPSTF Recommends Hypertension Screening for All Adults

Hypertension is one of the most common physical health issues today. According to the Centers for...

EEOC Announces New Rules For Wellness Program Incentives

On June 11, 2020, the U.S. Equal Employment Opportunity Commission (EEOC) voted in favor of a ...

Amazon Sued Over COVID-19 Employee Safety Concerns

For many employers right now, it isn’t just health fears or financial concerns alone that are...