Apple Considered Buying Medical Clinic Startup Crossover Health

Apple considered purchasing medical clinic startup Crossover Health as part of its push into healthcare, reports CNBC. Apple is said to have participated talks with the healthcare company up until recently, but after months of discussion, no deal materialized.

According to its website, Crossover Health works with major companies to provide employees with on-site medical clinics. Some of its existing customers include Facebook, Microsoft, LinkedIn, Square, and Apple, with many of these companies offering on-campus medical care.


Citing three sources with knowledge of the talks, CNBC says it's not clear why no acquisition ultimately happened between the two companies. Apple also talked to One Medical, another startup that offers patient clinics in several different cities.

Whether Apple would use such a startup to develop public-facing actual medical clinics or use existing facilities to sell products and gather data is not known.
The discussions about expanding into primary care have been happening inside Apple's health team for more than a year, one of the people said. It is not yet clear whether Apple would build out its own network of primary care clinics, in a similar manner to its highly successful retail stores, or simply partner with existing players.
Apple has made serious inroads into medical care with the introduction of CareKit and ResearchKit. CareKit is aimed at helping app developers create health-related apps to allow consumers better access to healthcare data, while ResearchKit is aimed at helping medical professionals develop studies to further medical research using data gathered from Apple customers.

Apple is said to be aiming to make the iPhone a "one-stop shop" for medical info, offering a centralized way to store all of a person's health data.

In the past, Apple CEO Tim Cook has said that health is an area that interests Apple because it's where hardware, software, and services can come together into "something that's magical." "We believe that health is something that is a huge problem in the world," said Cook in 2016. "We think it is ripe for simplicity and sort of a new view, and we'd like to contribute to that."


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Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools

The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products.

Companies accepted to the program include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

With its program, the FDA is aiming to create a more tailored approach toward digital health technology by looking at the software developer rather than the product to establish a firm-based pre-certification program for these digital health tools. The companies accepted to the program will be reviewed for software design, validation, and maintenance and to determine if they meet the FDA's quality standards for pre-certification.

Companies who have been pre-certified may be able to submit less information to the FDA before marketing a new digital health tool, speeding up the approval of new services and technologies. The FDA is also considering allowing pre-certified companies to avoid submitting products for premarket review in some situations.

As part of the program, Apple will provide the FDA with access to the measures it use to develop, test, and maintain software products. Apple has agreed to allow visits from FDA staff and offer information about its quality management system.
"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb. "We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
For Apple, this program could be a major boon as it has several digital health-related tools like Health, CareKit, and ResearchKit, and FDA approval is likely one of the major roadblocks to releasing new health-related products that are rumored to be in the works, such as some kind of device for monitoring blood glucose.

Apple CEO Tim Cook has said that Apple does not want to put the Apple Watch through the FDA approval process, but should the program go well, Apple may also have fewer regulations to contend with when it comes to the future of the Apple Watch, which could allow for new, more advanced health-monitoring capabilities.


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