The Verge - Healths |
- COVID-19 variant boosters won’t need new clinical trials for clearance, FDA says
- On a post-Roe v. Wade internet, unvetted abortion support is going viral
- How to delete your period tracking app data
- COVID-19 booster shots should target omicron variants, FDA says
- The fall of Roe v. Wade shows how little control patients have over medical records
| COVID-19 variant boosters won’t need new clinical trials for clearance, FDA says Posted: 01 Jul 2022 07:50 AM PDT  COVID-19 vaccine manufacturers won't need to conduct new clinical trials as they develop booster shots targeting the most recent variants of the virus, a Food and Drug Administration official told Reuters. The agency will use clinical trials of variant-specific boosters developed earlier in the pandemic, manufacturing data, and animal studies to evaluate the shots. The omicron variant of the virus has developed into multiple lineages. Right now, the BA.4 and BA.5 variants are the most widespread in the United States. The FDA said Thursday that the next set of booster shots should be against those versions of the virus. But pharmaceutical companies have been testing shots targeting BA.1, an earlier omicron lineage. Early data from Moderna and Pfizer / BioNTech shows that those shots generate a strong immune response against the omicron virus — including the BA.4 and BA.5 lineages, although to a lesser extent than BA.1. Pfizer has also tested a BA.4- and BA.5-specific booster in mice, and they presented that data during an FDA committee meeting this week. Relying on existing data will let the FDA and COVID-19 vaccine makers move more quickly to make booster shots available. But the virus is still spreading rapidly, and they may not be ready in time to stave off a BA.4 / 5 wave. The FDA said it hopes to have new COVID-19 boosters available this fall. "This fall we have to go all out on our booster campaign," said Peter Marks, head of the agency's Center for Biologics Evaluation and Research. |
| On a post-Roe v. Wade internet, unvetted abortion support is going viral Posted: 01 Jul 2022 05:30 AM PDT  Since the Supreme Court overturned Roe v. Wade last week, ending the constitutional right to terminate a pregnancy, social media platforms have buzzed with anger, dismay, and offers of assistance, particularly from people in states with stronger abortion protections. But a particular type of offer has captured media attention. In viral tweets, TikToks, and screenshotted and reshared Instagram posts, people are opening their homes up to abortion patients who must travel for care. "If you choose to have an abortion, and need a place to stay, there is always a bed for you at my apartment in Portland. Free. No questions asked," reads one tweet, liked more than 150,000 times and retweeted by more than 20,000 people. Providing lodging or transportation to appointments has long been part of practical abortion support, and organizations have honed their methods through decades of experience. With the fall of Roe, there's heightened urgency from people who perhaps weren't doing this work before but now want to. Making an offer of accommodation feels like a tangible and direct way to help. But organizations who have been coordinating lodging and transportation services worry that an influx of one-off, public, and unvetted offers arranged via social media could put patients and volunteers in dangerous situations. Jade, who coordinates volunteers and trainings with the Northwest Abortion Access Fund, says volunteers go through a number of steps and screenings before they're able to host abortion seekers in their homes. After a brief intake form, the fund conducts phone screenings, trainings, and walk-throughs of homes, making note of how accessible it is — especially for people just coming out of a procedure — who has access to the space, and whether there's privacy for patients. NWAAF paused home stays during the pandemic, and staff members are working on retooling their process in preparation for relaunching the program. The preference for abortion funds, Jade says, is that people needing a place to stay after their abortion go through reputable organizations that know what they're doing. It's a challenge to balance an appreciation for the influx of volunteers and additional resources with very real security and safety concerns, and Jade says they've been concerned about the issue as the SCOTUS decision neared. For one, abortion resources like funding, transportation, and lodging already come from a variety of sources, and accessing them is often difficult or confusing — now add in thousands of individuals and new groups offering up couches, air mattresses, and guest rooms. And without training or experienced staff to facilitate something like a homestay, a relatively risky arrangement could become even more fraught. "The worry I have is that if there's no vetting process, and there's not a clear place to go to stay somewhere safe, that harm could happen from well-intentioned people," Jade says. Even worse, the volunteer hosts may be in bad faith. Anti-abortion individuals welcoming patients into their homes could try to talk someone out of getting their abortion, similar to how crisis pregnancy centers operate, or patients could end up being in physical danger. Unmediated and unvetted stays could be dangerous for hosts, too. Recent anti-abortion laws suggest the future of abortion is one that criminalizes not just people seeking reproductive care but also those that help them access it. The restrictive Texas abortion ban passed last year, for example, allows people to sue doctors, advocacy organizations, volunteers, family members, and anyone else who helps a patient get an abortion (the ban was temporarily blocked by a Texas judge this week). "There are more legitimate risks right now to being someone publicly advocating for abortion in general," Jade says. "It gives the potential for folks to find your address, your phone number, get in contact with you, and generally know what you're up to." That risk isn't a concern for Janie Harvey Garner, a nurse and the creator of the Volunteer Aunties Facebook group, which was started the day of the Dobbs v. Jackson Women's Health Organization decision overruling Roe. Volunteer Aunties is one of many offshoots that have popped up since last week, and it's grown to around 3,500 members, many of whom Harvey Garner recruited through another Facebook group for healthcare workers she moderates. Harvey Garner says she's not trying to reinvent the wheel — she's simply hoping to connect volunteers with groups already doing abortion access work. "My goal is to hook these volunteers who are in a demographic that follows me with existing organizations," Harvey Garner says. At this point, the group's goal isn't to match individual abortion seekers with resources, but she says if someone did join the group looking to help, she would point them to available resources. But choosing a public platform like Facebook groups to organize pro-choice volunteers is far from foolproof — several members have raised safety concerns about using the platform to coordinate with each other. People joining Volunteer Aunties must answer a handful of screening questions before being added, but Harvey Garner believes that the group is already being monitored by anti-abortion users. "I'm quite sure within the first 1,000 [members] there were people who were anti-woman," she says. How platforms themselves will respond to a post-Roe world is still unclear and is unfolding in real time as people face new challenges to abortion access. Earlier this week, Meta clarified that posts offering to mail abortion pills violate its policies on pharmaceutical drugs. Even the online sharing of information about abortion is under legal threat. New groups or individuals popping up to provide resources often aren't equipped to respond to the myriad of situations that can arise as a person goes through the steps of getting an abortion, says Marisa Falcon, executive director of Apiary for Practical Support. These less-experienced actors may not have yet thought through the questions that veteran organizations have, such as how to minimize a patient's digital footprint, how to respond to a crisis before or after a procedure, and how to protect patient privacy. Offers of couches and guest rooms may have gone viral on social media, but many practical support groups have intentionally moved away from volunteer housing in recent years, Falcon says. Her organization provides resources and trainings to abortion groups offering housing, childcare, meals, transportation, and other support and maintains a first-of-its-kind directory of providers. "What clients want and need, by and large, is a private hotel room," she says. "They do not want to be sitting at the house, let alone on the couch of a stranger." Falcon and Jade both say that what organizations really need is money and patience that will allow them to serve abortion seekers most effectively. For people who want to help, that means plugging into the groups nearby that are active, which tend to be unfunded and under-resourced already and are bracing themselves for even more acute need as abortion protections are chipped away. "A lot of this sort of outpouring of support is about people wanting to offer the things that they want to offer and not necessarily thinking about the needs and interests of the clients," Falcon says. "We need to be talking about what people need, not what people want to give." |
| How to delete your period tracking app data Posted: 30 Jun 2022 12:35 PM PDT  Warnings to delete cycle tracking apps flooded social media in the wake of the United States Supreme Court's decision to overturn Roe v. Wade and end federal abortion protections. The data those apps contain, people feared, could be weaponized in court. As abortion starts to be criminalized in parts of the country, fears around personal data aren't unfounded. People who seek abortions in jurisdictions where it is now banned aren't wrong to worry that their data could be used against them. But experts say that data from period tracking apps probably isn't the biggest risk in a post-Roe landscape. People should be more worried about more mundane data — things like search history and text messages. Even if they aren't the primary weapons against people who might need abortions, period tracking apps do have sensitive information. These apps collect information on when people are in various stages of their menstrual cycle and can let people track things like PMS symptoms and sexual activity. Some offer to predict windows where people are most likely to become pregnant. The sheer volume of data can offer some insight into someone's reproductive health. Theoretically, if they show someone stop menstruating for a few months and then start up again, it could hint that they may have had a pregnancy end. And the apps, like most digital health devices, aren't protected by medical privacy laws. The companies who make them have broad leeway to decide what to do with the information they collect. Even ones with firm privacy policies say that they'll give information to law enforcement if they're required to by a warrant or subpoena. But so far, at least, period tracking app data hasn't been used to prosecute people suspected of breaking laws criminalizing abortion or other health care. It is a possibility and one people should take seriously, Cynthia Conti-Cook, a technology fellow with the Ford Foundation's gender, racial, and ethnic justice team, told The Verge. It's unlikely, though, that it'd be the main form of evidence used against someone suspected of having an abortion. /cdn.vox-cdn.com/uploads/chorus_asset/file/23663819/Logging_Symptoms.jpg) Image: Flo Period tracking can be a useful way to keep tabs on overall health or to monitor any reproductive health-related issues. Based on what experts are seeing so far, it's not a huge danger for people who like having that information on hand and likely isn't exposing them to a major risk. But it's also not unreasonable to be nervous about tracking any reproductive health-related information in light of the shifting landscape around abortion. So, if having the data sitting on a phone or server makes you uncomfortable, here's what you can do: How to delete tracking dataIt's easy to delete a period tracking app from your phone. Unfortunately, deleting an app doesn't guarantee that your health data has been deleted along with it. For example, if you were to delete the Flo app, the company could retain your data for three years in case you decide to re-download the app. This is because while some period tracking apps store data locally on your phone, many store your data in the cloud. In the case of the latter, your period data can remain accessible to the company and third parties unless you delete your account first. If you're unsure which type of period app you have, try to remember if you created an account when you first downloaded the app. If so, the app likely stores at least some of your personal data on its servers. For these apps, you must deactivate your account in order to delete your data. That said, be aware that deactivating your account doesn't mean the company has immediately deleted all your personal data either. Some period tracking apps may take several weeks to comply with the deletion process. It's a good idea to follow up by emailing customer support to ensure that your request has been honored. There are thousands of period tracking apps in Apple's App Store and the Google Play Store, each with its own privacy policies. While it's impossible to list how to delete each one, here's how to get started for some of the most popular period tracking apps, what their data retention policies are, and some general guidelines to follow. /cdn.vox-cdn.com/uploads/chorus_asset/file/23663766/Ovulation_Screen.jpg) Image: Flo Flo:
Glow:
/cdn.vox-cdn.com/uploads/chorus_asset/file/23663783/Period_tracking_Clue_01.jpg){kind=tracking} Image: Clue Clue:
Ovia:
/cdn.vox-cdn.com/uploads/chorus_asset/file/23663795/ios15_iphone13_pro_health_cycle_tracking_predictions.png){kind=tracking} Image: Apple Cycle Tracking on Apple Health:
Deleting data from period tracking apps that locally store data is easier, as the bulk of your data will be erased once you delete the app. However, you should still do your due diligence. Before you delete the app:
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| COVID-19 booster shots should target omicron variants, FDA says Posted: 30 Jun 2022 08:25 AM PDT  COVID-19 vaccine manufacturers should include the newer forms of the omicron coronavirus variant in booster shots this fall, the Food and Drug Administration recommended today. The agency said it wants vaccine manufacturers to create booster shots that include two forms of the virus — the original strain, which is what's in current vaccines, and the BA.4 and BA.5 lineages of the omicron variant. Those lineages have taken over as the most common form of the virus circulating in the United States. They're highly contagious and are even better at evading the immune system than some previous versions of the virus. Vaccine manufacturers Pfizer, Moderna, and Novavax have already been testing omicron-targeted versions of their vaccines, which early data showing that they can help trigger a stronger immune response to the omicron variant than existing shots. The versions they've been testing, though, include an earlier form of the omicron variant — the BA.1 lineage. Companies should do additional clinical trials on BA.4 and BA.5 shots, the FDA said in a statement, but should still send in data from the BA.1 shots. The current iterations of the COVID-19 vaccines still protect extremely well against severe disease and death, but a combination of waning immunity and new variants has left people less protected against infection. Experts hope that the next generation of shots will offer longer-lasting protection against the disease. |
| The fall of Roe v. Wade shows how little control patients have over medical records Posted: 29 Jun 2022 10:18 AM PDT  The end of federal abortion rights quickly made a common, safe medical procedure illegal in many parts of the United States and turned routine medical data into something that can be used against people suspected of having an abortion. Despite being highly sensitive, health data often isn't as private as people might assume. There isn't much preventing medical records from being weaponized against people seeking abortions in states where it is illegal. Even though medical records contain sensitive, personal information, most people don't have much control over the information in them or how they are shared. Medical privacy laws like the Health Insurance Portability and Accountability Act (HIPAA), don't stop subpoenas or warrants for medical records data, and under those laws, doctors are able to share medical information if they suspect a crime has occurred. "If you're in a state where something is just flat out illegal, there aren't really legal protections that prevent your medical records from being used against you," says Carly Zubrzycki, a health law professor at the University of Connecticut School of Law. Most patients don't own their own medical records. Only one state — New Hampshire — gives people explicit ownership over their medical records. In some other states, laws specifically say that medical providers or hospitals own the records. "Most health systems will claim it's their property," says Eric Perakslis, the chief science and digital officer at the Duke Clinical Research Institute. "And that they have a right to it." HIPAA, the law governing medical privacy, requires that people are able to see their full medical records. But research shows that the process is often complicated and that clinicians sometimes don't comply with policies designed to help people access their records. Even if someone manages to get full access, it can sometimes be missing things like clinicians' notes or other details. Tracking down the complete picture can be difficult for anyone without the time and resources to advocate for themselves. If they are able to get a full picture, patients are also able to request amendments to their medical records if they think something is inaccurate. Records often include decontextualized information, and it can be easy for people to spin that into whatever story they want to tell. With laws in place criminalizing abortion, people might want to make sure that their records are clear about how and why they sought out certain medical procedures. Doctors and hospitals, though, don't have to agree to make that amendment. "How can you even request changing things when you can't get basic access to your medical information?" says Jennifer Miller, a bioethicist at the Yale School of Medicine. "That's troubling." It'd be even more difficult to try to adjust medical records to keep out something that did happen, like a pregnancy-related procedure that could be deemed illegal. "There's not any formal mechanism by which you can insist that something true be taken out of your record," Zubrzycki says. The conversations between doctors and patients may play out differently on the ground, and some doctors might be more open to requests to make changes — or to keep information from entering the record in the first place, Zubrzycki says. But that depends on the doctor being trustworthy and a patient having the experience, knowledge, and resources to self-advocate around their medical data. It'd be a case-by-case situation. So, patients don't have control of what goes in their records. But they also have limited control over where that opaque, unchanging medical record goes. Hospitals and healthcare providers can share patient medical data with their business partners. They can also share personal medical information from patients with third parties as long as it's stripped of identifying information. And they do this all the time — hospitals regularly sell patient health data to tech companies, research groups, and pharmaceutical companies. That can put the security of medical records (and the privacy of patients) at risk. De-identification isn't perfect, and research shows that it's possible to tie supposedly anonymized medical records back to individuals. And anonymized buckets of data sent around by hospitals pose risks as well, says Perakslis. "When you target a community, you will probably end up harming individuals," he says. For example, anonymized data about patients that seek abortions at a hospital could theoretically be used to find groups of patients that anti-abortion groups might focus on for misinformation campaigns or that law enforcement might target for prosecution, Perakslis says. Policies designed to make it easier for doctors to share information about patients also yank medical records further out of patients' control. In some cases, laws require that doctors send medical records to each other when treating a patient — and the moves don't require the patients' knowledge or consent. Easy transfer of medical records is a longstanding goal for health experts, and in most cases, it improves patient care. But abortion bans and restrictions reveal some downsides to the free flow of information, Zubrzycki says. She outlined the risks in an upcoming Yale Law Journal Forum article: if medical records can follow people doctor to doctor, they can also follow people state to state. So the records of someone getting pregnancy-related care in a state that allows abortion could be sent back to their doctors in a state that criminalizes abortion — where it could theoretically be used against them if they were suspected of an abortion back home, she argues. Laws that stop anti-abortion states from obtaining medical records from doctors in states providing abortions — like one newly passed law in Connecticut — wouldn't necessarily stop this from happening. They block physicians from sending information in formal criminal or civil proceedings but don't appear to stop records from traveling between providers and between states during normal patient care. "I think that's a big risk and that worries me," Zubrzycki says. The criminalization of abortion throws into relief just how little control most people have over their medical records. And it reframes medical data as something that can hurt patients rather than something that helps them. That could erode trust between patients and doctors — and lack of trust often leads to people avoiding getting care at all, reproductive or otherwise. "This is a case that resurfaces concerns about the role of privacy and the doctor-patient relationship," Miller says. "When there's a lack of trust in the system, people disengage." |
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