FDA

The FDA issued new draft guidance aimed at improving interoperability among connected medical devices, Clinical Innovation & Technology reports.

Details of Draft Guidance

The draft guidance provides connected medical device manufacturers with:

• Design considerations for developing interoperable medical devices; and
• Information to include in pre-market submissions and device labeling (Walsh, Clinical Innovation & Technology, 1/26).

FDA noted that "errors stemming from inadequate interoperability can occur, such as the transmission of weight in kilograms when the receiving medical device assumes the measurement is in pounds, and that can lead to patient harm and even death" (Conn, Modern Healthcare, 1/26).

FDA called on device manufacturers to:

• Conduct appropriate performance testing and risk management activities;
• Design systems with interoperability as an objective;
• "Exer[t] command and control" over other devices;
• Publicly share the functional, performance and interface characteristics; and
• Standardize architecture and communication protocols.

The agency also said manufacturers should consider whether their devices can handle data:

• That have been "corrupted"; or
• From "outside ... appropriate parameters." 

FDA in its draft guidance said, "Increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost," adding, "However, appropriate safety considerations, including system-level safety considerations that are not taken into account in the device design can result in unforeseen safety and effectiveness issues for the device or for the system."

Reaction

Joseph Smith, chief medical and science officer at the West Health Institute, praised the draft guidance's expansion of the definition of interoperability to include actual use of shared data. He said, "Only through automatic use of information are we going to take full advantage of the many separate gifted gadgets to create an integrated and automated, connected and coordinated whole."

Meanwhile, Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said, "All FDA has the legal authority to do is convey through guidance what the agency expects in the way of appropriate labeling, design, validation and so forth for products that the manufacturer intends to be interoperable with some other devices." He added, "FDA can and does play an important role in defining the minimum required labeling, design, validation and so forth to support a product intended to be interoperable" (Bowman, FierceHealthIT, 1/26).

Cybersecurity Advocacy Group Calls for Universal Principles

In related news, a cybersecurity advocacy group has published an open letter to the health care industry to adopt five principles for creating, using and maintaining medical devices, Computerworld reports.

The group, called I Am the Cavalry, urged medical device manufacturers and other health care stakeholders to:

• Capture and analyze evidence of potential failures;
• Collaborate with security researchers;
• Implement security by design;
• Provide easy-to-install security updates; and
• Safeguard critical elements for operation in adverse conditions.

To achieve the goals proposed, the group, among other things, recommended:

• Avoiding known flaws;
• Avoiding unsecure remote access;
• Implementing proven processes for receiving vulnerability reports; and
• Making the medical device update process more secure (Constantin, Computerworld, 1/19).

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).

Background

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).

FDA launched a new mobile application that allows users to share and obtain information about drug shortages, Modern Healthcare reports.

Details of App

The app, which is available at no cost on iTunes and Google Play, is part of an FDA plan to mitigate drug shortages.

Through the mobile app, users can identify:

• Current drug shortages;
• Drug discontinuations; and
• Resolved shortages.

To identify such information, users can search for a drug's generic name or active ingredient, or they can search by therapeutic category (Ross Johnson, Modern Healthcare, 3/4). In addition, users can report suspected drug shortages or supply issues to FDA.

Valerie Jensen, associate director of drug shortage staff at FDA's Center for Drug Evaluation and Research, said, "FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decision," adding, "The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information" (AHA News, 3/4).

According to FDA spokesperson Christopher Kelly, FDA plans to release additional apps for stakeholders to access other information (Modern Healthcare, 3/4).