A new Senate bill aims to expand protections for Americans' health and location data. It follows concerns that such information could be used to identify individuals seeking reproductive health care services after the Supreme Court overturned the constitutional right to abortion last year.
The Upholding Protections for Health and Online Location Data (UPHOLD) Privacy Act seeks to block companies from selling personally identifiable health data for advertising purposes and ban data brokers from buying and selling precise location data. Moreover, the proposed legislation would afford consumers more access to and ownership over their health data. It would also place more restrictions on companies’ use of personal health data without the explicit consent of a user.
The bill aims to prohibit the use of personally identifiable health data from any source for advertising. This includes data from users themselves, medical centers, fitness trackers and browser histories. The UPHOLD Privacy Act's restrictions wouldn't apply to public health campaigns.
The legislation was introduced by Democratic Sens. Amy Klobuchar, Elizabeth Warren and Mazie Hirono. “With Republicans working to ban and criminalize reproductive health care nationwide, it’s critical we safeguard the reproductive data privacy of everyone in our country,” Hirono said in a statement. “Everyone should be able to trust that personal data about their bodies and their health care will be protected. By restricting the sale and use of personally identifiable health data, this bill will give patients and providers the peace of mind that their private information is secure.”
Since the Supreme Court overturned Roe v. Wade last June, legislators have not made much headway toward protecting consumer health data. Period-tracking apps have given some particular cause for concern. Developers of some of these apps have since introduced features and policies to help protect their users' data.
The Federal Trade Commission said soon after the Supreme Court ruling that it would clamp down on companies which misuse health and location data. This week, the agency moved to ban online counseling service BetterHelp from sharing consumers' health data for ad targeting without consent. The FTC found that the company shared users' email addresses, IPs and health questionnaire responses. BetterHelp says it has never shared clinical data from therapy sessions with advertisers, publishers or social media companies.
This article originally appeared on Engadget at https://www.engadget.com/new-senate-bill-aims-to-better-protect-health-data-after-roe-reversal-211457607.html?src=rss
Despite the repeated and audacious claims by its sometimes CEO, Elon Musk, the prospects of brain-computer interface (BCI) startup Neuralink bringing a product to market remain distant, according to a new report from Reuters. The BCI company was apparently denied authorization by the FDA in 2022 to conduct human trials using the same devices that killed all those pigs — namely on account of; pig killing.
"The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue," current and former Neuralink employees told Reuters.
The FDA's concerns regarding the battery system and its novel transdermal charging capabilities revolve around the the device's chances of failure. According to Reuters, the agency is seeking reassurances that the battery is "very unlikely to fail" because should it do so, the discharge of electrical current or heat energy from a ruptured pack could fry the surrounding tissue.
The FDA is also very concerned with potential problems should the device need to be removed wholesale, either for replacement or upgrades, due to the minuscule size of the electrical leads that extend into the patient's grey matter. Those leads are so small and delicate that they are at risk of breaking off during removal (or even during regular use) and then migrating to other parts of the brain where they might get lodged in something important.
During Neuralink's open house last November, Musk's confidently claimed the company would secure FDA approval "within six months," basically by this spring. That estimate is turning out to be as accurate as his guesses for when the Cybertruck might finally enter production. “He can’t appreciate that this is not a car,” one employee told Reuters. “This is a person’s brain. This is not a toy.” Neuralink did not respond to requests for comment.
This article originally appeared on Engadget at https://www.engadget.com/fda-reportedly-denied-neuralinks-request-to-begin-human-trials-of-its-brain-implant-204454485.html?src=rss
The Federal Trade Commission has moved to block online counseling company BetterHelp from sharing health data, including mental health information, with the likes of Facebook and Snapchat for advertising. As part of a proposed order, BetterHelp has agreed to pay $7.8 million to consumers to settle charges that it shared sensitive data for advertising purposes after promising to keep the information private.
This marks the first time the agency has reached an agreement with a company to return money to consumers after their health data was allegedly compromised. The order will be subject to public comment for 30 days before the agency decides whether to finalize it.
If the order comes into effect, it will ban BetterHelp from sharing data from users (including those who accessed the company's website or app without signing up for its services) with select third parties for ad targeting. The FTC alleges that BetterHelp shared users' email addresses, IPs and health questionnaire responses with Facebook, Snapchat, Criteo and Pinterest. The agency said this allowed Facebook, for instance, to target similar users with BetterHelp ads, which helped to drive tens of thousands of paid users and millions of dollars in revenue to the counseling company.
The FTC claims BetterHelp didn't receive explicit consent from users before sharing their health data, which it pledged to keep private except for limited uses, such as counseling purposes. In its complaint (PDF), the agency also accused BetterHelp of not limiting the scope of how third-party companies could use the health data it shared with them.
"When a person struggling with mental health issues reaches out for help, they do so in a moment of vulnerability and with an expectation that professional counseling services will protect their privacy,” FTC Bureau of Consumer Protection director Samuel Levine said in a statement. "Instead, BetterHelp betrayed consumers’ most personal health information for profit. Let this proposed order be a stout reminder that the FTC will prioritize defending Americans’ sensitive data from illegal exploitation."
The proposed order, which FTC commissioners approved unanimously, will require BetterHelp to, among other things, obtain explicit consent from users before sharing their data with some third parties for any reason. The company will need to establish privacy protocols to protect user data and delete personal and health information after a certain period of time. Moreover, BetterHelp will have to instruct the companies it allegedly shared user health and personal data with to wipe such information from their servers.
This article originally appeared on Engadget at https://www.engadget.com/ftc-moves-to-ban-betterhelp-from-sharing-mental-health-data-for-ad-targeting-184605314.html?src=rss
Amazon's months-long effort to acquire One Medical is finished — for now, at least. The company has officially completed its $3.9 billion purchase, giving it a primary healthcare provider with in-person and virtual treatment as well as lab tests. The successful buyout isn't leading to any immediate changes in One Medical's services beyond a temporary $55 discount on a one-year membership (now $144), but Amazon said last July that it planned a "reinvention" of healthcare with the takeover.
The completion comes just a day after the Federal Trade Commission said it wouldn't contest the buyout. However, the regulator also says it's still investigating the deal to explore potential anti-competitive effects and privacy concerns raised by Amazon's access to health data. An FTC official toldCNN the agency will warn Amazon it's closing the purchase at its own risk, and might still face a government challenge later.
Amazon has spent years making deeper forays into healthcare. It bought PillPack in 2018 and used the provider to launch an in-house pharmacy service. The online shopping heavyweight also introduced an app-based health service for employees in 2019 that it later offered to other companies. In 2021, the company introduced a custom Alexa for healthcare. The One Medical move theoretically completes the picture by letting Amazon handle everything from minor doctor's appointments through to prescriptions.
Whether or not Amazon could endure an FTC challenge isn't clear. Commission chair Lina Khan is known to be wary of Big Tech, and her stance even prompted Amazon to ask for her recusal from antitrust cases. There's no certainty the FTC might succeed, though, and it recently lost an effort to block Meta's purchase of Within. One Medical is considerably larger than Within, though, and its healthcare focus brings up privacy concerns that aren't always present in tech acquisitions.
The Federal Trade Commission has slapped prescription drug discount app GoodRx with a $1.5 million fine for the unauthorized disclosure of customers' identifiable health information with third parties, such as Facebook and Google. This is the first time the agency has taken enforcement action under its Health Breach Notification Rule, which requires vendors of personal health records to notify customers if their data has been breached. While the rule has applied to companies handling health records since 2009, FTC commissioners voted in favor of expanding it to cover health apps in 2021.
According to the FTC, the California-based telehealth service repeatedly violated the rule by sharing customers' personal health information, including their health conditions and the medicine they're taking. Further, it shared their information with companies that have third-party advertising platforms like Facebook, Google and Criteo despite making a promise to customers that it will never do so. The FTC says GoodRx also monetized its customers' information. In 2019, for instance, it uploaded the email addresses, phone numbers and mobile advertising IDs of users who purchased certain medications to Facebook, so it can target them with health-related ads.
In addition to imposing a $1.5 million fine on GoodRx, the FTC is also seeking to change how the company handles user information. In its proposed court order (PDF) against the company, it listed several provisions, including banning the service from disclosing user data for advertising purposes. For other purposes, it wants to require GoodRx to secure customers' consent first before sharing their health information to third parties. The FTC also wants GoodRx to get the third parties it shared data with to delete its customers' information, and it wants the company to establish a comprehensive privacy program that will protect user data.
Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said in statement:
"Digital health companies and mobile apps should not cash in on consumers' extremely sensitive and personally identifiable health information. The FTC is serving notice that it will use all of its legal authority to protect American consumers’ sensitive data from misuse and illegal exploitation."
Ultrasound can provide detailed images of your heart, but the bulk makes it impractical for continuous scanning — especially outside of the hospital. It might be far more portable in the future, however. Researchers have developed a wearable ultrasound patch that provides real-time heart imagery, even while you're in motion. It also uses deep learning to automatically calculate ventricle volume and generate performance stats. You'd know your cardiac output at any given moment, for instance.
The device uses piezoelectric (that is, pressure-powered) transducers to perform deep tissue imaging. Stretchable liquid metal electrodes, meanwhile, ensures the ultrasound imager can stay close to your skin while remaining compact. Past attempts at wearable ultrasound arrays have relied on thin metal films that limits the design's complexity.
The technology isn't close to production. Scientists want to continue miniaturizing the system, which still needs to attach to an external processing system through a flexible cable. The team also hopes to improve the spatial resolution through better algorithms, and use a larger AI training dataset that could better reflect the general population.
Some of the advantages are already clear, mind you. The creators believe the wearable ultrasound could provide continuous metrics for patients with heart disease or in critical care, including outpatients. Remote ultrasound scans have been envisioned before, but have frequently relied on wands or other cumbersome gadgets. The tech could also be helpful for athletes hoping to strengthen their hearts and optimize their abilities.
The concept isn't limited to one organ, either. The designers say their wearable ultrasound system could be generalized for use with the spine, liver and veins. In that light, the tech could provide freedom to many patients and athletes who'd otherwise need to visit clinics or hospitals to share data for their conditions.
Amazon has launched a new subscription service that will let customers in the US get as many eligible medications as they need for $5 a month. The new service called RxPass is part of the e-commerce giant's Pharmacy business that originally launched in 2020 as a two-day prescription drug delivery offering for Prime users. That makes RxPass a $5 add-on for Prime, which sets users back $139 a year or $15 a month in the US.
While it doesn't look quite as affordable bundled with Prime pricing, the RxPass program does offer medications for 80 common health conditions, including high blood pressure, acid reflux, anemia and even depression, diabetes, breast cancer and dementia. At the moment, it has 60 generic medications in its list — all of which require a valid prescription — and subscribers can choose to have them delivered for free either on a monthly or a quarterly basis.
Take note that customers will need to pay $5 out of pocket, since the service does not take insurance like Amazon Pharmacy does for purchases outside of the program. People who are enrolled to Medicare, Medicaid and any other government healthcare program will not be able to sign up for RxPass, as well, though they can still use their government insurance when purchasing medicine from Pharmacy.
For people with multiple conditions paying a lot more than $5 a month for their medications out of pocket, RxPass could be worth trying out, especially if they already have Prime. Those interested may want to take a look at the service's full medication list first to see if it does offer what they need before heading to the Pharmacy website or the Amazon app to sign up.
Martin Shkreli, whom you may know as "Pharma Bro," launched a new company last year called "Druglike, Inc." Now, the Federal Trade Commission (FTC) has asked a federal judge to hold him in contempt for failing to cooperate with the agency in its investigation to determine whether launching the company violates his lifetime industry ban. US District Court Judge Denise Cote imposed a lifetime ban on Shkreli that prohibits him from participating in the pharmaceutical industry early last year. Cote ruled that the former pharma exec orchestrated an illegal anticompetitive scheme to gain a monopoly over Daraprim, a life-saving anti-malarial and anti-parasitic drug.
After Shkreli's former company, Turing Pharmaceuticals, obtained the manufacturing license for Daraprim, it raised the drug's prices from $17.50 to $750 per tablet. Cote sided with the FTC in the antitrust lawsuit the agency filed against Shkreli in 2020 and ordered him to pay $64.6 million in damages, in addition to imposing a lifetime industry ban against him. Prior to Druglike's launch, Shkreli tried (and failed) to convince a judge to put the ban on hold, arguing that the public could benefit from his future contributions to the industry. Shkreli challenged the ban while he was serving time in federal prison after receiving a seven-year sentence in 2017 for defrauding investors. He was released from prison in May.
The FTC said it started asking Shkreli for a compliance report and access to relevant records, as well as asking him to sit for an interview regarding Druglike, in October 2022. However, the company co-founder kept on disregarding its "repeated requests." The agency also said that Shkreli has yet to pay any amount of his $64.6 million fine. It's now asking the court to order Shkreli to comply with its information requests within 21 days of its decision.
In a press release (PDF) for its launch, Druglike described itself as "a Web3 drug discovery software platform." The company said it's building a "decentralized computing network" that "provides resources for anyone looking to start or contribute to early-stage drug discovery projects." In a statement, Shkreli said "Druglike will remove barriers to early-stage drug discovery, increase innovation and allow a broader group of contributors to share the rewards."
In a 2022 report about VR fitness, The Washington Post cited a Forrester research that said 25 percent of American adults online are interested in buying a VR headset and 18 percent think they'd primarily use it for exercise. VR fitness is a growing space, and Meta has rolled out a couple of new health-related features for its Quest headset that could convince even more people to give it a try. In its latest update for the device, the company has rolled out Health Connect integration for Android users, and, as The Vergereports, the ability to pair Bluetooth heart rate monitors with it.
A Meta spokesperson told the publication that if paired with a compatible heart rate monitor, the Meta Quest Move overlay can display a user's heart rate on any game or app, alongside minutes exercised and calories burned. At the moment, the only known compatible monitors are the Garmin HRM-Dual and the Polar H10 chest straps, but other brands and models (even smartwatches) may be able to pair with the headset. Meta just can't confirm if they'll work with the Quest as it intended.
Meanwhile, Health Connect integration will give users the capability to automatically sync VR workouts with their Android device. Meta first made people's VR fitness stats viewable outside of their headsets when it gave iOS users the capability to sync their progress with Apple Health last year. Now, Android users can finally see their progress without having to put on the Quest, as well.
The Health Connect API enables health and fitness data sharing across devices and between apps, such as Samsung Health and MyFitnessPal. To activate the integration, users will first have to sync their Meta Quest Move stats with the Meta Quest mobile app. They can do so by going into the Move app in VR and clicking Settings. Users will then have to toggle on "Health Connect by Android" under the Connected Apps section inside the Meta Quest mobile app.
It's unclear if these features are also making their way to the first Quest model released under the Oculus branding. A few days ago, the company sent out emails to Quest 1 owners, telling them that their devices will no longer be getting new features going forward. Meta will also only be releasing critical security and bug patches for the device until 2024.
One swallow doesn’t make a summer, and I’m not sure if you can count four instances of a product as a trend, but it’s certainly an interesting thread at this year’s CES. At this year’s show, a quartet of companies are showing off urine analysis tools designed to be used at home by the general public. These are positioned as a natural evolution of the fitness tracker, a device you can use to keep an even closer eye on your health and fitness. Most of them are built for your toilet, testing your pee for any number of easy-to-identify maladies. But is this the next great frontier of consumer health tracking? That rather depends on the public’s desire to delve deep into their own bladders.
My cynical take: I suspect the reason we’re seeing these pop up is because the wearables world is now played out. Back in 2019, I wrote that we’d reached the point where there were no new features that could be fitted to a smartwatch, fitness tracker or ring. Or, at least, none that were as valid, effective or accurate as what you now expect every device on the market to offer. Once it was possible to put a single lead ECG in a watch, there were no new health-tracking worlds left to conquer that didn’t involve breaking the skin.
Dr. Audrey Bowden is Dorothy J. Wingfield Philips Chancellor Faculty Fellow, Associate Professor of Biomedical Engineering at Vanderbilt University, and head of the Bowden Biomedical Optics Laboratory. Dr. Bowden tells Engadget that clinical urinalysis is used as a “first line screening for many diseases and conditions such as diabetes and kidney disease,” but added that it can “also play a role in ordinary, routine checkups, such as during pregnancy.”
You may have seen your physician ask you for a urine sample and then stir a dipstick dotted with colored squares of reaction paper into the liquid you’ve just produced. In addition to visually checking urine for cloudiness (an obvious sign of a problem), these squares can run a wide variety of tests as part of this first-line screening process.
Each square corresponds to a different test, looking for factors like pH as well as the presence of blood, or white blood cells. Blood, for instance, can indicate kidney stones or cancer, while white blood cells are a clue your body is fighting an infection. If there’s excess glucose in the urine, it’s likely that diabetes is the culprit. Ketones would indicate ketosis, nitrites could indicate bacteria in the urinary tract, and so on.
Dr. Bowden added that for many conditions, urinalysis is not a “definitive diagnostic, but rather serves as an initial prompt to perform a more complete investigation.” And that since the clinical procedure has been to test for urine when there’s already evidence of a problem, it’s not clear how effective daily testing can really be.
A medical professional I interviewed, who requested anonymity for fear of compromising their professional standing, expressed skepticism both about the accuracy of these tests as well as their utility. They said that if people were running tests at home on a regular basis, it runs the risk of providing hypochondriacs with another reason to clog up care centers.
Dr. Shubha K. De (MD) is a Urologic surgeon who is presently working on a PhD in biomedical engineering. He raised a concern that, in primary care facilities, medical staff know how to validate the data they’re presented with, and to screen out false positives. This may not be the case in an at-home setting, and added that the accuracy of some tests vary wildly — a dipstick test to identify a bladder infection is roughly 80-percent accurate, but to diagnose bladder cancer, it falls to just 3 percent.
The most talked-about gadget at CES is surely Withings’ U-Scan, which even Jimmy Kimmel joked about in his opening monologue on Thursday. Given that Withings is already such a big name in the health-tracking world, it’s little surprise that it’s hogged the attention. The company showed off a device that sits on the dry part of your toilet bowl, and samples some of your trickle as you pee. Once that fluid is captured inside the device, it runs a sample through a microfluidic cartridge (with reaction paper) and uses a reader to look at the result. Once completed, the results are sent to your phone, with suggestions on what you might do to improve your health.
When it’s eventually released, U-Scan will offer a cartridge for menstrual cycle tracking, as well as one to monitor your hydration and nutrition levels. It’s this latter cartridge I tried during my time in Vegas this week, and it looked at the pH of my urine as well as the specific gravity (relative density) of my pee. But the company promises that it will eventually be able to identify nutrient levels, fat metabolism, ketones and quantities of vitamin C.
Both of these have raised red flags with professionals who are concerned that these analyses don’t suit a one-size-fits-all model. Dr. Bowden said that menstrual cycle tracking based on “‘normalization’ curves may have been developed with too narrow a demographic to capture all interested users.”
Dr. Bowden was also resistant to the idea that nutritional information can be extracted given clinical urinalysis doesn’t offer data about those markers. She said urine samples don’t really “provide reliable information over a given time window,” and added that a “daily analysis of food nutritional content may be a stretch.” Although she did say that it may be possible to detect “accumulated nutritional deficits.”
Dr. De, however, says that it may be possible to extrapolate nutritional information back to a person’s diet using urine analysis. They said that physicians currently ask patients to run 24-hour urine collections, and that fluid is then examined for specific substances — like uric acid — to make inferences on dietary intake. “This is not always perfect, and currently needs some correlation with one’s diet history,” but added that it’s plausible to imagine that, with a “user friendly app and some AI” that it could work well.
Withings is looking to develop more clinical tests, and has said that it’s already working on a way to screen for bladder cancer markers. It’s here that my source who asked not to be named feels would offer real value to groups who are at risk of the disease. They said that a targeted monitoring program may help identify instances of the cancer early, which should dramatically increase survival rates.
Daniel Cooper
Korean company Yellosis graduated from Samsung’s startup incubator some years ago, and already produces the Cym Boat personal urine testing kit. Cym Boat offers a small stick with reaction paper squares, which you then stand in a boat-shaped piece of card lined with color-calibration squares. Take a picture on your smartphone, and you’ll be able to look at the blood, protein, ketones, pH and glucose levels within your urine.
At the show, it also showed off its next-generation product, Cym Seat, which uses a metal arm to hold a paper stick under a person as they pee. Once completed, it slides the strip in front of an optical scanner, and after a minute, the results are pushed to your phone. But this device, which is expected to launch by the end of 2023 and cost around $1,000, automates the existing process rather than adding anything new.
Daniel Cooper
Similarly, Vivoo, which also offers a reaction-paper stick which can be analyzed by a smartphone app, is building its own toilet-mounted hardware, which pushes a pee stick into the toilet bowl and then pulls it back in once it’s collected a urine sample. An optical scanner then reads the reaction squares before depositing the stick in a collection bin for disposal later.
Daniel Cooper
Rounding out the group is Olive, which is taking a dramatically different tack. The device harnesses spectroscopy rather than reaction paper, with hardware that sits under your toilet seat, and a bank of LEDs flashing toward rear-mounted photodiodes. The potential for such a technology is far greater than reaction paper, and there are some studies that have pointed to being able to identify infection with it.
Olive is presently being used in a handful of locations in the Netherlands, including an assisted living facility. Co-founder Corey Katz told Engadget that one of the most surprising uses for the technology was for personnel to keep accurate records of patient bathroom visits. Katz added that work is presently under way to find a way to measure levels of protein in urine to identify instances of preeclampsia.
The company says that there’s a broad number of conditions that spectroscopy could be used to test for. This includes hydration and ketosis all the way through to stress, creatinine levels and electrolyte balances. The hope is that a finished version of the hardware will be ready to go by the end of 2023, although it’ll only be sold to business customers.
There are issues, including around data security, especially for menstrual cycle tracking in countries like the US. Companies that could expose fertility data will need to be mindful of the legal context that is presently in place post-Roe.
If Dr. De has a final concern, it’s a worry that these at-home devices will encourage patients to take medical matters into their own hands without the supervision of a physician. “If [urine analysis systems] direct you to take supplements which jeopardize pre-existing medical conditions,” for instance, “then it could be quite dangerous.”
Of course, there are other things that independent experts (and journalists) will need to test when these devices make it out into the real world. Dr. Bowden raised concerns that urinalysis tests can be “impacted by a number of external factors,” which clinical settings make an effort to control for. Will these devices be accurate enough for the jobs they’ve been bought to do? And will the conclusions they provide be worthwhile? There’s a lot to work through before these products become ubiquitous in bathrooms around the world.