FDA: The budget, the clearance, the plans

With help from Arthur Allen (@arthurallen202) and Mohana Ravindranath (@ravindranize)

PROGRAMMING NOTE: Morning eHealth will not publish on Monday, Feb. 19. The newsletter will return Tuesday, Feb. 20. Please continue to follow PRO eHealth issues here.

FDA — THE BUDGET, THE CLEARANCE, THE PLANS: FDA is looking like the most active agency when it comes to digital health these days. Let’s recap what it’s up to:

— The budget: Commissioner Scott Gottlieb posted a long statement Tuesday outlining his agency’s budget asks. It’s no surprise that Gottlieb has software on the mind. Gottlieb wants to “establish a new capability … to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals in a broad range of U.S. healthcare settings.”

Gottlieb’s effort is intended to cover the range of medical products — from drugs to medical devices — and examine health care settings not currently covered by the agency’s preexisting surveillance efforts, Sentinel and NEST. There’s also a mention of “natural language processing,” which presumably would allow computers to ingest and make sense of normal prose as opposed to numbers.

Another FDA interest earned a mention in that section: the use of so-called real-world evidence to speed up approvals.

Gottlieb’s statement also shouts out the agency’s digital health pre-certification pilot. In this concept, the agency would certify developers as employing good software design practices, and thereby streamline the approval process for their products.

Gottlieb is establishing a “Center of Excellence on Digital Health,” which we presume will hold the new software-focused recruits authorized by the most recent user fees agreement. The center will support the agency’s cybersecurity capabilities, intended to help manufacturers shore up their defenses against digital attack. The agency has become more attentive to risks posed by balky cyber defenses.

— The clearance: FDA gave a notable thumbs-up Tuesday to software from startup Viz.AI that analyzes CT images and flags potential stroke in text messages to specialists. That has the potential to cut out a radiologist’s review, and thereby speed the process of delivering care to stroke victims.

The clearance has more general interest. The agency has been trying to figure out how to categorize and regulate clinical decision support software. Its recent guidance on the subject attracted initial relieved huzzahs, as the agency had worked for years on it; but the gratefulness was followed by sustained criticism later. We’ll see how things progress in this area.

— The plans: Just after the New Year, the agency took a pretty relevant meeting with Pew Charitable Trusts, according to its public calendar.

As we mentioned earlier, Gottlieb and FDA are interested in using real-world evidence to surveil and approve products — and Pew’s longstanding passion for unique device identifiers dovetails perfectly. Pew’s Ben Moscovitch told Morning eHealth that, as part of the meeting, the organization advocated for the inclusion of UDI in claims forms as the perfect tool for the agency. Moscovitch said it would help “achieve the agency’s goal of generating better, real-world data on product performance to streamline approvals without sacrificing patient safety.”

eHealth tweet of the day: Aaron Albright @AaronKAlbright

“I still love thumbing through ICD-10 codes.

‘Drowning and submersion due to falling or jumping from other burning powered watercraft, initial encounter’
Initial encounter?”

WEDNESDAY: A real worlds-colliding moment as a former Epic Systems software engineer fell at Final Jeopardy, the local paper reports. Your correspondent, sadly, must refrain from any snark directed at either Epic or Jeopardy; despite semi-persistent attempts to get on the show (or win at HQ), his trivial depths are no match for his competitors. Advise your correspondent about better trivia practices at [email protected]. Test trivia skills socially at @ravindranize, @arthurallen202, @dariustahir, @POLITICOPro, @Morning_eHealth.

OTHER BUDGET REQUESTS: HHS’s Office of the Inspector General posted its budget justification Tuesday. Among other responsibilities, the office pursues fraudsters — and it’s enthusiastic about using data to do so. (It uses “Data Driven Decision Making to produce outcome-focused results,” in fact.) The document doesn’t mention its information blocking enforcement responsibilities; the office’s James Cannatti told the Senate HELP committee last October that it was preparing to do so, though without a specific timeline. ONC is expected to release a rule defining what constitutes information blocking this spring.

STRANGE ACQUISITIONS: DARPA, the Pentagon’s research and development unit, wants technology that can assess whether someone has been exposed to biothreats, including any components used to build weapons of mass destruction.

DARPA is looking for proposals for a system that could reveal a person’s history of exposure to certain molecules, according to a new announcement on FedBizOpps. Current analysis relies on residue from the actual production of those weapons, which would require a high-concentration sample of that residue.

A FEW FCC NOTES: Commissioner Mike O’Rielly wants to sell an even bigger chunk of 3.5 gigahertz spectrum than previously planned. That part of spectrum might be used for new-generation 5G wireless networks, or other purposes; certainly, the health care field will get its piece of fancy wireless gadgets.

— And, personnel notes: Roger Sherman, a former FCC official, has signed up to lobby for wireless trade group CTIA

COMPANIES’ CHESS MOVES: Corporations are moving around the chess board to position themselves for the future of health care. Wearables manufacturer Fitbit acquired startup Twine Health Tuesday. Twine offers chronic care management coaching … In an apparent countermove to the proposed CVS-Aetna tie-up, Walgreens and drug distributor AmerisourceBergen are in talks to merge, the Wall Street Journal reports. Amazon is apparently interested in selling hospitals medical supplies, as opposed to some of the other fantastical plans that have been attributed to the company, various people report.

AMIA HAS RECOMMENDATIONS: The American Medical Informatics Association has scads of policy recommendations in a new white paper released Tuesday. The paper is the fruit of an earlier AMIA-convened conclave of its members, and includes recommendations for more patient-defined measures and methods of tracking the sources of some data and its re-use, among other ideas.

WHAT WE’RE CLICKING ON:

—Consumer Reports: Keeping track of your medical records is key to protecting your health.

—Utah is considering a bill to authorize a telemental health pilot in schools

—A Tennessee hospital was hacked by malware, which attempted to commandeer the computers for cryptocurrency mining purposes.