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  • 1.  Apple Store

    Posted 11-Sep-2020 17:01
    Not sure how new this is but Apple Store is now requiring regulatory approval documentation from any locale you provide a medical based app for download via the Apple Store. Our app is useless without the partner hardware patch so I will let you know how that argument goes.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------


  • 2.  RE: Apple Store

    Posted 12-Sep-2020 08:34
    hello Ed,

    This is quite interesting. I would suppose since Apple has its own devices now, or even competing  Apps . Wonder  when it becomes an Anti-trust issue. Who are they to gate other apps and judge if a clearance is needed.

    Oh yeah Evil Apple.

    Not a fan of Apple after experiencing  their egotistical attitude on startup in the 80s in Silicon Valley...i never voluntarily  buy their products. I can see I will have a problem in the future when they control all the EHRs.


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: Apple Store

    Posted 14-Sep-2020 08:27
    On e of our SW engineers speculated that by making it harder for Apples competitors to place apps it gives Apple an advantage in that market. Hmm

    ------------------------------
    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 4.  RE: Apple Store

    Posted 14-Sep-2020 09:28
    Not too surprised here. They got pushed hard politically a few years ago and have clearances for all their apps, so I am not surprised they are trying to keep the playing field level. I'd rather have "show external approval" than some arbitrary internal standard they use.

    Now, if one wants to discuss how their 510(k)s magically get cleared a few days before their planned way ahead "lunch" announcements.....

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 5.  RE: Apple Store

    Posted 14-Sep-2020 10:09
    Hi Ginger

    Yeah..FDA Visitor logs show they were talking to Bakul Patel at FDA 2 years before they got their first clearance.   No surprise here.  And I think FDA likes hob nobbing at Stanford.   It is a pretty campus (lived there 6 years on campus  in grad married housing).  The Silicon Valley craze.  Great weather, but too pricey, too crowded, horrible traffic and people too self-satisfied with  themselves for my taste.... was there  1984-1991.  Gave up weather AND earthquakes for freezing passive aggressive MN/WI. Ha!  

    Ginger

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 6.  RE: Apple Store

    Posted 14-Sep-2020 12:25
    I worked for Apple for several years (in a field office capacity - only going to the Cupertino mothership for the annual Team meeting).  The company did get the needed clearances for its health related product features, and recognizes the Regulatory process and documentation required.​  Through apps now too (Android, Apple and other platforms alike, although introduced nationally/globally by Apple), home healthcare is experiencing a renaissance of sorts.  I am grateful for all of these new advantages (including the fall detection capability in an immediate family member's Apple watch, which she tends to wear a lot more than she ever wore her single purpose 'help/alert button', plus the helpful EKG and heart rate features, etc.).  I'm sure Apple's approach and the company's risk analysis in all app approval situations has not been perfect.  However, I believe there would be more people on a feed here if Apple was not completing the needed regulatory steps (and fighting it all instead in the courts constantly, as some companies tend to do).  Plus, I know some there at Apple feel as though they have to be twice as diligent, because there is the concern, the government is more likely to make an example out of such a large organization.  Some product announcements too are indeed scheduled months in advance, but some are scheduled just a few weeks out, if that (like the one tomorrow) or just made via a press release.  I'm just offering a different perspective here.  I hope you all have a good day.​

    ------------------------------
    Reuben Lidster
    Regulatory Affairs Specialist
    Bloomington IN
    United States
    ------------------------------

    Original Message


  • 7.  RE: Apple Store

    Posted 15-Sep-2020 16:13
    Thanks for providing something of an inside perspective.

    I was also thinking that Apple's product development is not funded by VCs and therefore, while they may be under typical industry competitive pressure, they not on a do-or-die breakneck schedule.  It seems to me that, if it looks like a product won't get clearance on its original planned launch date, Apple can afford to postpone as needed and if wanted, without anyone threatening to pull its funding.   Nor is it likely to perish from the most common cause of death for medical device startups if it has to wait a bit..."We ran out of money."

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: Apple Store

    Posted 15-Sep-2020 01:32
    Edited by Julie Omohundro 15-Sep-2020 16:08
    This has never struck me as quite as strange as it seems to strike many others. 

    Apple has the resources to put together a solid submission and to match its schedule to FDA's, as much as the other way around.  And it can actually plan a launch date, if it wants to, as opposed to device industry standard, which can be more like praying for one. :)

    Combine that with Donna Bea as their RA consultant, it just doesn't seem that strange.  Extra effort because it's Apple, sure, just not like something from another planet.

    I could easily see a small device company pulling this off, if it had a reasonably agreeable reviewer and its ducks neatly in a row.  I have a harder time seeing a small device company having its ducks in row, but it could happen.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 9.  RE: Apple Store

    Posted 14-Sep-2020 23:54
    Edited by Jennifer Ng Ain Kin 15-Sep-2020 00:20
    Edward

    Was this direct communication from Apple to your firm about your app?

    I am looking at their recently updated Apple Store guidelines https://developer.apple.com/app-store/review/guidelines/. Interestingly the latest update to the guidelines was just when you posted on September 11, 2020) and I see this line (highlighted) under 1.4 Physical Harm

    • 1.4.1 Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny.
      • Apps must clearly disclose data and methodology to support accuracy claims relating to health measurements, and if the level of accuracy or methodology cannot be validated, we will reject your app. For example, apps that claim to take x-rays, measure blood pressure, body temperature, blood glucose levels, or blood oxygen levels using only the sensors on the device are not permitted.
      • Apps should remind users to check with a doctor in addition to using the app and before making medical decisions.
      If your medical app has received regulatory clearance, please submit a link to that documentation with your app.

    I don't know if this is a new requirement or not but definitely interesting. One of the rationale for being more stringent could be due to the many "covid-19 Apps" that have sprouted on the Apple Store since the pandemic and that should not be there? 

    Best Regards,
    Jennifer

    ------------------------------
    Jennifer Ng Ain Kin
    WW Regulatory Affairs, Advertising and Promotion
    Santa Clara CA
    United States
    ------------------------------

    Original Message


  • 10.  RE: Apple Store

    Posted 15-Sep-2020 00:41
    Ah Jennifer 

    Cynical me thinks your optomistic view is like the Pinkie swear (as Julie calls it) of the Pharma execs, holding them selves  to higher standards.  I have to stop chortling now.

    I suspect nefarious  reasons, not beneficence on Apple's part.  What better way to get deep regulatory intelligence " tell us your validation methodology" - really?

    Honestly  who made them FDA? From a consumer perspective maybe yay...but from a competitive view and Antitrust, this screams lawsuit abuse of power/platform.
      


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 11.  RE: Apple Store

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2020 15:25
    This message was posted by a user wishing to remain anonymous

    I used to work for a company with PMA product and apps, and we were often scanning the field. We saw a lot of others who would check the box that they met all FDA requirements when they clearly did nothing. Some of these apps were dangerous. A distributor would not distribute physical product without some kind of confirmation of regulatory clearance/approval, but an app store could look the other way as long as the app developer checked a box that said they met the requirements. I'm glad to see Apple is taking this requirement more seriously now.
    Original Message


  • 12.  RE: Apple Store

    Posted 16-Sep-2020 10:11
    Here is more context from Apple.

    1.4 Physical Harm

    If your app behaves in a way that risks physical harm, we may reject it. For example:

    • 1.4.1 Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny.
      • Apps must clearly disclose data and methodology to support accuracy claims relating to health measurements, and if the level of accuracy or methodology cannot be validated, we will reject your app. For example, apps that claim to take x-rays, measure blood pressure, body temperature, blood glucose levels, or blood oxygen levels using only the sensors on the device are not permitted.
      • Apps should remind users to check with a doctor in addition to using the app and before making medical decisions.
      If your medical app has received regulatory clearance, please submit a link to that documentation with your app.
    • 1.4.2 Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, pharmacy or other approved entity, or receive approval by the FDA or one of its international counterparts. Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.
    • 1.4.3 Apps that encourage consumption of tobacco and vape products, illegal drugs, or excessive amounts of alcohol are not permitted on the App Store. Apps that encourage minors to consume any of these substances will be rejected. Facilitating the sale of marijuana, tobacco, or controlled substances (except for licensed pharmacies) isn't allowed.
    • 1.4.4 Apps may only display DUI checkpoints that are published by law enforcement agencies, and should never encourage drunk driving or other reckless behavior such as excessive speed.
    • 1.4.5 Apps should not urge customers to participate in activities (like bets, challenges, etc.) or use their devices in a way that risks physical harm to themselves or others.
    https://developer.apple.com/app-store/review/guidelines/

    ------------------------------
    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


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