In the wake of new privacy concerns post-Roe, the FTC has warned companies and data brokers that it would crack down on any misuse of health and location data. The agency stopped short of detailing any new steps to safeguard sensitive reproductive health data but stressed it would hunt down companies that break existing data privacy laws. In a new blog post, the FTC wrote that it was “committed to using the full scope of its legal authorities” to safeguard consumer privacy. It also noted that apps that track periods and fertility, as well as any product that collects health or location data could expose individuals to harm, particularly those seeking abortions.

“The Commission is committed to using the full scope of its legal authorities to protect consumers’ privacy. We will vigorously enforce the law if we uncover illegal conduct that exploits Americans’ location, health, or other sensitive data. The FTC’s past enforcement actions provide a roadmap for firms seeking to comply with the law,” wrote the agency’s acting associate director in the Division of Privacy and Identity Protection Kristin Cohen in the post.

The FTC’s statement arrives only a few days after the Biden administration’s July 8th executive order on abortion access, in which it asked the FTC to take steps to protect abortion data privacy, including launching a task force. In light of the Dobbs ruling, digital privacy groups have warned that police can easily use location tracking and other sensitive data to prosecute those suspecting of having an abortion in states where it is now illegal.

Period-tracking apps are just one of the many tools that law enforcement agencies can use to build a case against a person suspected of having an abortion. As both digital privacy groups have noted, fitness trackers, search histories, GPS map apps and practically any online activity could be fair game for law enforcement in states with abortion bans. Location data can also be misused. The FTC noted a 2017 Massachusetts case where a company sent targeted ads on abortion alternatives to anyone who crossed a “digital fence” outside an abortion clinic.

Perhaps as an example of how aggressive it has been with apps that misused reproduction health data in the past, the FTC also mentioned a settlement it reached last year with popular period-tracking app Flo. The agency had alleged that Flo shared sensitive health data with outside parties, despite promising to keep such information private. As a result, Flo agreed to obtain user consent prior to sharing information with outside parties and to launch an independent privacy review. Flo is hardly the only reproductive health app to share sensitive user data. A May study of 20 different period-tracking apps by VPN company Surfshark found that nine shared data for third-party ads and 10 collected coarse location information.

In January, doctors at the University of Maryland School of Medicine made history by successfully transplanting a pig's heart into a human. The 57-year-old patient may have died two months later due to complications from the experimental procedure, but the case has inspired scientists throughout the medical field to call on the FDA to expand the scope and scale of human-porcine transplantation research. During a two-day conference in late June, policy advisors to the FDA and medical professionals discussed the future of xenotransplantation and "most attendees agreed that human trials are needed to help answer the most pressing research questions," according to Nature. 

We've been stuffing pig organs into sick people since the early 19th century, but the technology has made rapid strides in recent decades thanks in part to the advent of CRISPR technology and more potent immunosuppressives. In 2017, researchers created the first human-pig hybrid embryo as well as devised a solution to potential inter-species viral infections. As of January, 2022, were implanting genetically modified pig kidneys into brain-dead donor recipients with great success.

“Our goal is not to have a one-off, but to advance the field to help our patients,” Dr. Jayme Locke, lead surgeon of the kidney study and director of UAB’s Incompatible Kidney Transplant Program, told the NYT. “What a wonderful day it will be when I can walk into clinic and know I have a kidney for everyone waiting to see me.”

Humans have also conducted numerous experimental pig-organ transplants into primates like baboons. But in order to safely and consistently do it with humans, researchers will have to test the techniques on humans, Caroline Zeiss, a veterinary specialist at Yale School of Medicine, told Nature. For example, doctors found traces of porcine cytomegalovirus (PCMV) in the heart transplant patient who died earlier this year and believe that it may have played a role in his demise, but they won't know for sure without further tests that a primate model — ones that can't be replicated in primates.

Researchers are only looking at “small, focused” clinical trials with “appropriately selected patients,” Allan Kirk, a transplant surgeon at the Duke University School of Medicine, told Nature. Researchers will have to answer a number of fundamental questions before the technology can be widely utilized, as well as determine the right mix of breeding and genetic tinkering needed to ensure that recipients' bodies won't reject them.

And while the decisions made during last week's meeting may not have an immediate impact on the agency's current stance on xenotransplantation, changes are reportedly afoot. The WSJ spoke to a "person familiar with the matter" at the end of June who asserts the FDA is planning to launch pig-organ transplantation trials in an effort ease the shortage of transplantable human organs (*angrily shakes fist at seatbelts*). There's no word on when such trials would launch as they are being handled on a case-by-case basis, the source said.     

The UK’s National Health Service has announced that it will test delivering vital chemotherapy drugs via drone to the Isle of Wight. The body has partnered with Apian, a drone technology startup founded by former NHS doctors and former Google employees. Test flights are due to begin shortly, and it’s hoped that the system will reduce journey times for the drugs, cut costs and enable cancer patients to receive treatment far more locally.

The Isle of Wight is an island two miles off the south coast of England with a population just under 150,000. Due to the short shelf-life of most chemotherapy drugs, medicines are either rushed onto the island or patients take the ferry to the mainland. This journey can take up to four hours, while a drone flight can run from Queen Alexandra Hospital to St. Mary’s Hospital in half an hour. Not long after and an additional pilot scheme will take place in Northumbria to see if it’s possible to deliver vital medical supplies at ultra-short notice.

It’s not the first time that drones have been used to deliver vital medicines faster than a conventional courier. Merck and drone company Volansi began testing the delivery of cold-chain medicines to patients in rural North Carolina. Similarly, drone technology has helped move blood supplies across Rwanda, deliver prescriptions to senior citizens in Florida and help with supply drops during COVID-19.

Similarly, the UK’s Royal Mail has tested using autonomous delivery drones to get packages to remote areas. That includes getting vital supplies to the islands of Scilly, Shetland, Orkney and the Hebrides. Much like the NHS trial, Royal Mail said that using drones would reduce carbon emissions and speed up delivery times, especially in far-flung regions where infrastructure costs are too excessive to even think about.

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the omicron BA.4 and BA.5 variants in addition to the original strain.

An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the omicron variant that caused a significant upswing in COVID-19 cases during the winter.

However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions. 

Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the FDA rejected Juul's application to keep selling tobacco- and menthol-flavored pods as well as its vape pen.

The decision doesn't apply to Juul pens and pods that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find those products in the near future.

In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping vs. cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).

In Juul's case, though, the FDA said the company's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."

The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

Juul can appeal the decision or challenge it in court. Engadget has contacted the company for comment. 

The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company's revenue comes from the US, The Wall Street Journal noted this week. 

Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and faced suits in several other states. 

The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who had used e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user's identity in an attempt to prevent underage use. 

Turns out the Apple Watch’s motion sensors can be a useful tool for Parkinson’s patients and their physicians. The FDA has granted approval to Rune Labs to use their software paired with the Apple Watch to track symptoms of Parkinson’s disease, Reutersreported today. The San Francisco-based digital health startup has created software for watchOS that can detect common Parkinson’s symptoms such as tremors, involuntary or slow movement, rigidity and poor balance. Smartphone and other remote forms of monitoring Parkinson’s have been around for a while, but this is the first software designed for the Apple Watch that the FDA has cleared for motion disorders.

Since the Apple Watch Series 4 was first released in 2018, the wearable has been able to detect hard falls and offer advanced activity metrics. The company that same year added a Movement Disorder API to its open-source ResearchKit, opening the door for developers to create watchOS apps to track Parkinson’s and other diseases. As Rune Lab notes, the company is the first to make use of the API for commercial purposes.

The watchOS app by Rune Labs will give physicians access to patient movement data over time, which can further supplement the information they get from an in-person physical exam. Rune Labs also notes the Apple Watch’s tools aren’t capable of giving patients a complete picture of their disorder. “Of course, there are limitations to Apple's Movement Disorder kit: tremor and dyskinesia are only two symptoms in Parkinson’s Disease, and the classifiers themselves are not yet perfect,” wrote Rune Labs founder Brian Pepin last year in a blog post.

Apple has focused a lot of time and money on expanding and updating the Watch's health and fitness tracking capabilities, with many more to come in future updates. Earlier this month the FDA also cleared watchOS's AFib History feature — which monitors irregular and extremely rapid heartbeat — and will be released in the upcoming watchOS 9 update. 

Shields Health Care Group, a Massachusetts-based company involved with imaging and health management services, has announced a major hack that could have exposed sensitive information for up to two million people. The company learned of the attack on March 28th, and after an investigation it found that a malicious actor had access to some of its systems between March 7th and 20th. 

Crucially, the hack included sensitive information like social security numbers, medical record information, patient IDs and insurance details. The company claims there isn't any evidence of identity theft from the incident, but there's still a chance customers could be compromised down the line. 

"Upon discovery, we took steps to secure our systems, including rebuilding certain systems, and conducted a thorough  investigation to confirm the nature and scope of the activity and to determine who may be affected," the company said in a statement. "Additionally, while we have safeguards in place to protect data in our care, we continue to review and further enhance these protections as part of our ongoing commitment to data security."

Shields says it has contacted the FBI, as well as local and state regulators, about the incident. According to the AP, the FBI isn't commenting on the attack yet. Moving forward, Shields says it will contact customers once it learns who's affected.

Apple is at last promising better sleep tracking for Apple Watch as part of watchOS 9. The Sleep app will add a sleep stage function. It will be able to detect the REM, core and deep sleep stages and track those over time. Those who participate in the Apple health research program will be able to submit their sleep stage data to researchers for a new study.

One of the more notable health features for watchOS 9 is that it will show how long a wearer is in a state of atrial fibrillation (AFib) if they have been diagnosed with the condition. The new feature will show the time of day or week that AFib is most active.

You'll receive weekly notifications to help you gain a better insight of AFib frequency. The Health app will show a detailed history, along with indicators of lifestyle factors that may impact the condition, such as exercise, sleep and alcohol intake. You'll be able to download a PDF that includes your aFib history and possible lifestyle factors to share with your healthcare professionals.

Apple Watch's electrocardiogram (ECG) tool can look for signs of an irregular heartbeat or AFib. The US Food and Drug Administration just granted Apple approval last week for an ECG history feature. 

In addition, Apple is introducing a Medications app to help users keep track of when to take their meds.

Developing...

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CVS will no longer fill prescriptions from telehealth companies Cerebral and Done Health for controlled substances. The pharmacy chain said that, following a review, it had unresolved concerns with both companies. The Wall Street Journal first reported the news.

"We are committed to making mental health services as accessible and convenient as possible. At the same time, it is important that medications are prescribed appropriately," CVS Health's executive director of corporate communications Mike DeAngelis told Engadget. 

"We recently conducted a review of certain telehealth companies that prescribe controlled substance medications. As a result of our being unable to resolve concerns we have with Cerebral and Done Health, effective May 26th, 2022, CVS Pharmacy will no longer accept prescriptions for controlled substances issued through these companies."

The startups have tens of thousands of patients between them, the Journal notes. They have prescribed stimulants such as Adderall for patients with attention-deficit hyperactivity disorder (ADHD). These stimulants are regulated and classed as schedule 2 controlled substances due to the risk of abuse.

Some other pharmacies, such as Walmart and Truepill, previously delayed or declined to fill prescriptions from the two startups. They reportedly had concerns that clinicians at Cerebral and Done were writing too many stimulant prescriptions.

It recently emerged that Cerebral is under investigation by the Department of Justice and the Drug Enforcement Administration. Following that news, the company put prescriptions for ADHD meds for new patients on hold. Cerebral said last week it would stop prescribing most controlled substances for all patients by October. Just two days after that, its board replaced CEO Kyle Robertson.

Along with ADHD, Cerebral says it treats depression, PTSD, anxiety disorders and serious mental illnesses through therapy, counseling and, in some cases, prescriptions. Done focuses on ADHD treatment. 

Before the onset of the COVID-19 pandemic, clinicians were banned from prescribing stimulants without an in-person visit with patients. Those federal rules were loosened in March 2020 for schedule 2 substances, which enabled Cerebral and Done to start offering prescriptions after virtual consultations.

Engadget has contacted Cerebral and Done for comment.

A team of UK scientists has analyzed the complete genetic makeup of 12,000 tumors from NHS patients and discovered 58 new mutations that provide clues about their potential causes. The team, comprised of scientists from Cambridge University Hospitals and the University of Cambridge, used data from the 100,000 Genomes Project. That's a British initiative to sequence the whole genomes of patients with cancers and rare diseases. 

Team leader Professor Serena Nik-Zainal said this is the largest study of its kind and that the vast amount of data her team worked with allowed them to detect patterns in the genetic alterations or "mutational signatures" found in the tumors. By comparing their results with other studies, they were able to confirm that 58 of the mutational signatures they found were previously unknown. Some of them are pretty common, while some are rare.

"The reason it is important to identify mutational signatures is because they are like fingerprints at a crime scene — they help to pinpoint cancer culprits," Nik-Zainal explained. Some signatures could show that past exposure to environmental causes such as smoking or UV light had triggered the cancer, while others could have treatment implications. They could, for instance, pinpoint genetic abnormalities that could be targeted by specific drugs. 

Professor Matt Brown, chief scientific officer of Genomics England said: "Mutational signatures are an example of using the full potential of [whole genome sequencing]. We hope to use the mutational clues seen in this study and apply them back into our patient population, with the ultimate aim of improving diagnosis and management of cancer patients."

In addition to conducting DNA analysis and publishing its results in Science, the team also developed an algorithm called FitMS that will give clinicians easy access to the new information they discovered. FitMS looks for both common and rare signatures in the results of a patient's whole genome sequencing test. Doctors can use the algorithm to find out if their patients exhibit any of the newly discovered mutations for a more accurate diagnosis and for personalized treatments.