Tag: mobile medical applications

HHS Launches HIPAA Platform for Medical Application Developers

On Monday, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform designed for use by developers of mobile medical applications (apps).  The site allows users to submit questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and to access […]

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health Insurance Portability and Accountability Act (HIPAA) rules addressing mobile health app developers.  The letter, […]

FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber threats and recommend manufacturers outline the necessary steps that will be taken if their devices are found to […]

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to […]

COOLEY ALERT Published: FDA Issues Final Guidance Regarding Mobile Medical Applications

We informed you earlier this week that the U.S. Food and Drug Administration’s (“FDA”) long awaited final guidance on mobile medical applications was released.  We have now published a Cooley Alert that analyzes the final guidance in greater detail.  The Cooley Alert is available at: http://www.cooley.com/FDA-issues-final-guidance-regarding-mobile-medical-applications.

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

Mobile Health Apps Implicate Data Privacy and Security Laws

Privacy concerns regarding mobile devices in health care are raising eyebrows and making headlines. The Telegraph reports that “health and fitness apps have been harvesting sensitive personal data and passing it on to insurance and pharmaceutical companies” although “apps companies . . . have denied that the information is personally […]

CMS Publishes FAQs for OPEN PAYMENTS Mobile Apps for Physicians & Industry

As we noted last week, CMS released two mobile apps for tracking reportable payments: one for physicians and one for applicable manufacturers and applicable GPOs. Both are available for download now for iOS (Apple™) and Android™ mobile phones.  New FAQs from CMS provide additional visibility into how CMS envisions physicians and industry using these […]

Sunshine in Your Pocket: CMS Releases Mobile Apps for Tracking and Reviewing OPEN PAYMENTS Data

Industry and physicians preparing to comply with federal sunshine provisions have a new resource available. To facilitate tracking and reviewing OPEN PAYMENTS Data, CMS has released two mobile applications (apps): one for physicians and one for applicable manufacturers and applicable GPOs. Use of the apps is optional and both are available […]

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]