“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
The family of a Texas man is suing after they say he died waiting for life-saving medication. On Dec. 7, 2023, Jerrold Allen, 79, went to H-E-B Pharmacy in San Antonio to pick up a prescription ordered by his doctor, according to a lawsuit filed by his son. But when Allen went to the pharmacy, he was told the prescription was filled and would be sent to him in the mail. “Allen was erroneously informed that H-E-B could not dispense the medication,” the lawsuit said. Four days later, on Dec. 11, Allen suffered a heart attack and died on Dec. 13, the lawsuit said. “H-E-B Pharmacy followed applicable standard of care. Because this matter is in pending litigation, we cannot comment further,” a statement from H-E-B Grocery Company to McClatchy News said. The lawsuit said his death was due to him “not taking the life-saving medication prescribed by his doctor that was to be dispensed by H-E-B Pharmacy.” Allen was a retired major general in the United States Air Force, according to his obituary. “Jerry loved to support young people in their pursuit of success and found great joy in witnessing their achievements,” the obituary said. H-E-B Pharmacy failed to obtain an override and failed to provide an emergency supply of the medication, according to the lawsuit, which also said the pharmacy was negligent in not informing Allen’s doctor about the issue. The lawsuit seeks between $250,000 and $1 million in relief to be decided by a jury.
One factory making CVS-branded pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. And a third made nasal sprays for babies on the same machines it used to produce pesticides.
The drugs were among those sold by CVS Health Corp., the largest US pharmacy, under its store-brand label before being recalled.
Other chains have seen their share of recalls for their own store-branded medications. But over the past decade CVS’s have been recalled about two times more than those from Walgreens Boots Alliance Inc. and three times more than those from Walmart Inc., a Bloomberg analysis of public records found. Both CVS and Walgreens say they offer more than 2,000 store-brand health and wellness products; Walmart declined to say how many it had for sale, but its website indicates it has many of the same drugs available as CVS and Walgreens do under its Equate store brand.
CVS Has Many More Store-Brand Recalls Than Rivals
Over-the-counter generics with safety concerns in the last decade
Source: Food and Drug Administration data
This potentially dangerous pattern has roots in the quality of the factories from which CVS sources its generic medicines, the findings show.
Big Take
CVS Drug Recalls Tied to Tainted Factories
There’s little incentive for large drug purchasers like pharmacies and hospitals to choose suppliers based on quality, said Kevin Schulman, a professor of medicine at Stanford University. Rather, they often choose the lowest-cost manufacturing contracts, which Schulman’s research has found leads to lower-quality medicines. “The best way to make a low-price product is to skimp on quality and that’s what we’re seeing over and over and over again,” he said.
When choosing suppliers, CVS prioritizes “good manufacturing and ethical sourcing practices and the ability to meet our strict standards and testing practices,” said Amy Thibault, a spokesperson for the company.
CVS-branded medication recalls represent fewer than 1% of US Food and Drug Administration drug recalls over the past decade, she added. The FDA’s drug recall database includes both prescription and non-prescription treatments. CVS’s store brands “are designed to maximize quality and safety, work as intended, comply with regulations and satisfy customers,” she said.
CVS brand allergy medicine that was recalled in January.Source: National Library of Medicine; 731 Illustration
Many consumers believe that drugstore brands are a cheaper, nearly interchangeable substitute for name-brand ones. Last November, Joan Collins, a 78-year-old from Nassau County, New York, purchased CVS eye drops to relieve irritation. Soon after using them, her eyes turned red and swollen and she developed headaches and started seeing double, according to a legal complaint she filed against the pharmacy chain in January. Collins was diagnosed with a severe eye infection, which a doctor attributed to the CVS eye drops. Collins ended up in the hospital for a week.
The eye drops Collins bought shouldn’t have been on CVS shelves at all. A month earlier, FDA inspectors had found peeling paint, barefoot workers and fabricated test results that gave the appearance of product safety at the facility in India where they were made. Samples taken at the factory also found bacteria in crucial parts of the production facility. While the FDA had warned consumers not to use certain CVS eye drops on Oct. 27, the drugstore chain still had them for sale two weeks later, when Collins bought them.
Even months later, Collins hadn’t completely regained her eyesight, according to the complaint.
CVS responded to Collins’ claims in court documents, saying that it sold the drops but denying “that the product at issue in this action had quality oversight issues or was unsanitary or defective in any respect.” The retailer also said that it isn’t responsible for the manufacturing process or quality control of the factories that make its generic drugs. The case is still pending in New York state court.
The use of contract manufacturers is increasingly attractive in the pharmaceutical industry because outsourcing is cheaper than building a production plant, said Michael de la Torre, chief executive officer at Redica Systems, a pharmaceutical data analytics firm. Larger drugmakers typically visit a supplier that’s either making an active ingredient or producing a finished product. This can help them see glaring problems like sanitation issues and evaluate manufacturing practices firsthand.
Drugmakers that outsource production to other companies are “legally responsible for approving or rejecting drugs manufactured by the contract facility, including for final release,” said Amanda Hils, a spokesperson for the FDA.
There is a loophole, however, for store-brand drugs. The agency considers pharmacy chains like CVS “private-label distributors.” In the case of the generics they hire others to make, it’s the manufacturers themselves that are responsible for the quality of the drugs, according to FDA guidance.
That setup has created a concerning gap in the oversight of everyday medicines that many Americans take to save a few bucks.
Over the last decade, CVS hired at least 15 manufacturers that were cited for manufacturing problems, more than twice as many as its largest rival, Walgreens. This led to 133 recalls of CVS store-brand drugs — an average of more than one a month — in that time frame for both pediatric and adult medications, according to a Bloomberg News review of FDA data. Walgreens had 70 recalls over the same period and Walmart had 51. CVS and Walgreens each have around 9,000 stores; Walmart has about half as many, though that doesn’t necessarily correlate to how many store-brand products they sell.
In one instance involving CVS store brands, FDA inspectors visited a contract manufacturer called Unipharma LLC in Tamarac, Florida, in 2019, and determined it had been ignoring test results that showed water used in its drugmaking was contaminated with a bacteria that can be deadly to children with weakened immune systems. The company, now defunct, recalled all of its non-prescription products, including cherry-flavored children’s pain and fever medicine, mixed berry children’s allergy relief and pineapple-flavored children’s cough syrup — all made so CVS could sell them under its own name. The drugs were distributed nationwide.
Sun Pharmaceutical Industries Ltd. recalled generic Allegra allergy medication it made for CVS after an FDA inspection at the company’s drug manufacturing facility.Photographer: Amit Madeheshiya/Bloomberg
More recently, a factory in Xiamen, China, that made burn cream for CVS home first aid kits was banned in October from sending drugs to the US because they were at risk of microbiological contamination. Sun Pharmaceutical Industries Ltd. recalled generic Allegra allergy medication it made for CVS in January after FDA investigators found stagnant liquid inside an air purification unit at the drugmaker’s facility in India that was later found to have yeast and mold colonies, according to an inspection report. Sun Pharmaceutical didn’t respond to requests for comment.
In response to questions from Bloomberg, CVS said it doesn’t visit the factories it hires to make store-brand drugs. CVS relies on a third-party auditor who visits any facility before the company begins working with it, and annually after that. Walgreens either sends its own representative or a third party to visit the factories with which it works. Walmart didn’t respond to questions about its practice.
CVS first started emphasizing store brands in 2014 and then put “considerable focus” on them four years later, Brenda Lord, vice president of store brands and quality assurance at CVS Health, told the National Retail Federation in a 2022 interview. CVS wanted to be a leader as consumers sought less expensive alternatives. “There’s no longer a stigma attached to buying cheaper store brands,” Lord said in the interview with the trade group.
CVS store-brand drugs are marked with a red heart and the words “CVS Health.”Patrick T. Fallon /AFP/Getty Images
The pharmacy chain’s drugs are marked with a red heart and the words “CVS Health” on the box or bottle. CVS doesn’t break out how much it makes from such products, though store-brand items of all kinds — from beauty and food to home and health — accounted for around a quarter of the company’s overall sales, Lord estimated at the time. Since then, the category across retailers has only grown, rising 4.7% to $236 billion in 2023 compared with 2022, according to the Private Label Manufacturers Association.
For retail pharmacies, including CVS, front-of-store sales — meaning anything not sold at the pharmacy counter — have been struggling for years with e-commerce and discount giants attracting more shoppers. To lure people back, drugstores are refreshing the stores and trying to carry more products that align with health and wellness messaging.
FDA officials have raised concerns before about lax oversight of contract manufacturers. In 2017, an official said the agency had sent multiple warning letters to companies for not keeping a close eye on manufacturers for hire. Several cases involved companies that hadn’t checked for particulates in eye drops. “They are just not even looking,” Francis Godwin, who monitored drug quality in the agency’s Office of Compliance, said at a conference that year.
Still, in 2019, CVS, Walgreens and Walmart had store-brand eye drops recalled. They stemmed from an FDA inspection that found workers at an Altaire Pharmaceuticals plant in New York were falsifying data to make their products appear safe. In the incident, CVS had many more types of drops recalled than its competitors. Altaire declined to comment.
US health authorities last year tied at least four deaths and several cases of vision loss to drops made at a factory in India. Those weren’t sold at CVS, but other retailers nationwide.
Brassica Pharma issued a recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, and CVS Health Lubricant Eye Ointment, and Lubricant PM OintmentSource: Food and Drug Administration (FDA); 731 Illustration
FDA officials found more red flags in other factories in India that supplied store-brand eye drops to the pharmacy giants. Agency officials who in January visited Brassica Pharma Private Ltd., which made drops for both Walmart and CVS, found operators touching the inside of tubes that were to be filled with sterile drug products, according to an inspection report obtained via a Freedom of Information Act request. Brassica also faked test results that were meant to detect microbiological contamination at the factory, according to the inspection report. Brassica Pharma didn’t respond to requests for comment.
The FDA generally inspects drug-production factories once every few years and doesn’t regularly test drugs Americans take. With companies under pressure to keep generic drug prices low, there’s little incentive to invest in additional quality control measures. And while recalls may get unsafe medications off of shelves, it doesn’t necessarily get them out of medicine cabinets — consumers aren’t always aware of the defective products.
“This sole emphasis on cost pushes the price down to the point where high-quality manufacturers don’t want to stay in the market,” Schulman said.
There has been a committee of a few pain advocates that have been working for several months on a proposed federal bill to help the chronic pain community regain their QOL with better pain management.
Some of those of us who were on that committee will be on www.waok.com at 8:30 AM EDT on Friday 06/14/2024 for a 30-minute discussion of what is involved in the Protection of American Medicine (AKA the PAM Act)
There will be a “call-in line”, I don’t have the number as of this post yet.
Suppose you ever wondered why you can’t get your Rx paid for by your insurance and the med your doctor prescribed. In that case, your insurance company will only pay for another medication and/or require your doc transverse some sort of paper shuffle nightmare to get your medication paid for. If you ever ask why your prescription costs so much. Pay attention to the alphabet soup of middlemen that the person in this video just starts to mention. Each one of these middlemen has an operational cost overhead and a desire to show a profit.
This article was written by Dr.Ezekiel J. Emanuel back in Sept 2014 the director of the Clinical Bioethics Department at the U.S. National Institutes of Health and head of the Department of Medical Ethics & Health Policy at the University of Pennsylvania helped develop President Obama’s health care reform law.AKA Obamacare
There are serious consequences of under-managed pain
It was the second time she had been to the emergency department with pain. It was also the second time she was sent home without answers. With each visit, I felt increasingly helpless as a nurse and a daughter, as my mom called me in excruciating pain on her way to the hospital.
After the first visit, I had helped her navigate the healthcare system and get appointments with various specialists and her primary care provider. Yet, here she was, in the emergency department a second time with unresolved, under-managed, and unbearable pain.
Many factors within the healthcare system contribute to under-managed pain in women — which is especially prevalent in older and middle-age women. I am all too familiar with the fact that we have a taxed healthcare system, but there is also an unfortunate history of dismissal of women’s pain. Pain in middle-age and older women is frequently dismissed as a “normal part of aging,” both within society and within healthcare. My mother, my patients, and my research participants have expressed far too many times that they left a visit with no plan for their pain, and were told it was just arthritis and to work on losing weight.
Under-managed pain in middle-age and older women is a deeply concerning issue. Yet, many fail to recognize the dire consequences. We need this to change.
The Consequences of Unmanaged Pain
Among those experiencing chronic pain, 70% are women. Under-managed pain in older women can lead to reduced quality of life, frailty, difficulty with physical activity, and poor mental health outcomes. Among middle-age and older women from underserved and underrepresented groups, under-managed pain only further expands the gap in access to necessary healthcare and contributes to health disparities. All this and I haven’t even gotten to the cost: chronic pain costs the nation an estimated $560-635 billion each year (in 2010 dollars) in pain management care, disability payments, and lost work productivity.
This is clearly an issue affecting not only those patients living in pain and their families, but society at large.
Acknowledging Their Voices and Responding to Their Pain
It’s high time to take action beyond just being aware of this burden of pain.
Chronic pain in women should be at the forefront of research agendas. We must find innovative ways to build on our previous work to better assess, treat, and understand chronic pain mechanisms and experiences among women. With the new White House Initiative on Women’s Health Research, it is imperative that researchers recognize chronic pain as a condition that disproportionately affects women and has severe consequences. As First Lady Jill Biden stated, no woman should have to hear “it’s all in your head.
We, as clinicians, must move forward from simply acknowledging that pain exists for middle-age and older women and make it a priority for their voices to be heard. It is imperative that we provide space and opportunities for women to go beyond the limited 0-10 pain scale and express their unique pain experiences. Using culturally aware assessment methods is also an important aspect of providing space for women to voice their pain and ask questions about it.
Through my research, I’ve learned that putting women at the center of their pain management is a crucial component in improving their pain and quality of life. For example, women in my study identified their goals in pain management, such as being able to sit or stand for longer periods at work, or to better manage their pain while at home. Building on their experiences, it is important that women can identify the goals they would like to achieve in their pain management rather than clinicians setting the goals and pain management regimens for them. We have found that when women express what is meaningful to them, their pain management plans are more sustainable and realistic, and their pain and mood also start to improve.
For clinicians specifically, pain management should be founded in shared decision making with middle-age and older women. In addition, developing pain management plans that are tailored to women’s needs is imperative in managing their pain and improving long term outcomes.
A Worthy Investment
We have the potential to change healthcare as we know it for women experiencing chronic pain. At first, it may cost more to go this extra mile, but in the end the costs of pain management and lost productivity would likely decrease. Most importantly, we owe it to women like my mom and the women in my research studies to hear and believe them.
It is the heartbeat of healthcare to believe our patients, and our duty to hear their stories and work with them to manage their pain. It is the duty of researchers and clinicians to respond to their stories to help improve outcomes.
According to Ballotpedia, politically she is a Nonpartisan but she received both her BS and JD degrees from the Catholic University of America. So apparently she was raised in the Catholic faith. Her ruling on this particular case would suggest that she is like our President, who professes to be a good-practicing Roman Catholic but appears to be pro-abortion. She is also another octogenarian bureaucrat who probably should have stepped down. This decision by this judge seems to have little empathy for a sickly 75 y/o woman who was “praying” at an abortion mill and is sentencing her to TWO YEARS IN PRISON. There is a high probability that this is LIFE SENTENCE for this poor woman. So much for her First Amendment rights of freedom of religion. You should read some of the judge’s rulings that are listed in the wikipedia.com link above on her, it would also appear that she has little use for our Second Amendment as well. According to this article, Harlow was praying at a notorious late-term abortion mill in Washington, D.C. Some believe that late-term abortion is – or should be defined as – infanticide.
Judge Sends 75-year-old Pro-Lifer to Prison for Two Years; Mocks Her Faith
A federal judge openly mocked a 75-year-old grandmother’s faith in the courtroom during a sentencing hearing. Paulette Harlow faces two years in jail for praying at an abortion mill.
Judge Colleen Kollar-Kotelly handed down the sentence, along with 36 months of supervised release, because of her part in a prayer and hymn sing at a notorious late-term abortion mill in Washington, D.C.
Harlow had been under house arrest since November 2023 because of her rapidly declining health.
Harlow’s husband pleaded with the court for mercy because of his wife’s declining health and feared that she might die in prison.
“In my heart, I think she’s having a hard time staying alive,” John said, according to LiveAction. “We’ve tried to be good people,” he later added. “I love my wife dearly… We’re throwing ourselves on the mercy of the court.”
Judge Kollar-Kotelly dismissed his concerns and mocked Harlow’s faith in Christ.
The judge quipped that she hoped Harlow would “make an effort to remain alive” because that is a “tenet of [Harlow’s] religion.”
In November 2023, Paulette was convicted of violating the Freedom of Access to Clinic Entrances Act and of “conspiracy against civil rights.”
Sen. Mike Lee condemned the federal judge’s callous remarks.
“This judged mocked Harlow’s religious beliefs while sentencing the 75-year-old woman in poor health to two years in prison — all for the offense of (gasp) praying at an abortion clinic,” Lee wrote on X. “Moloch is a vile monster.”
In May 2024, Paulette’s eight co-defendants were also sentenced to various lengths of time in prison followed by supervised release. On May 14, Harlow’s co-defendant Lauren Handy was sentenced to almost five years in prison.
Paulette has remained under house arrest since November 2023 due to her medical needs.
In her statement for the government, prosecutor Rebecca Ross insisted the case was “not about the defendant’s beliefs,” but rather about “violent obstruction of reproductive healthcare” and “violating the civil rights of others.”
Ross accused Harlow of attempting to use her poor health as an “excuse” to “escape the consequences” of her actions and of lying under oath at her trial, though exactly how Harlow allegedly did the latter was not made clear.
The attorney claimed that Harlow “denied empathy and compassion” to women attempting to abort their children on the day of the rescue, and recommended a sentence of 33-41 months.
I have watched these “GLP-1” ads on TV. I found it curious that these ads were promoting “GLP-1” injectables for “diet”. GLP-1 is just the “category” of this group of medications. The FDA rule is that a pharmacy CANNOT compound a medication that is similar/same to a commercially available product – unless the commercial product is unavailable or in a shortage status.
This is the same thing that pain clinics use in having a pharmacy to compound meds that go into the implanted pumps. They have the pharmacy compound Hydromorphone because there is no commercially available preservative-free Hydromorphone or they will add some lidocaine-type product, clonidine, or other meds to just about any opioid to get the pharmacy to compound the meds to go into a pump. There is only one FDA-approved med to be used in implanted pumps – Infumorph – which is Morphine in a preservative-free injectable. Just read this article and see the price these companies charge for the GLP-1 compounded meds vs the cost of the FDA-approved GLP-1 category of brand-name injectables. This should give you a general idea of why pain clinics use compounded meds to be put in implanted pumps. You have to follow the $$$.
Another online pharmacy bypasses the FDA to offer cut-rate weight loss drugs
Hims & Hers Health, one of the online pharmacies that got its start prescribing dick pills, is now offering knockoff versions of GLP-1 weight loss drugs. Hims & Hers says it will offer drugs that mimic Ozempic and Wegovy, the active ingredient of which is semaglutide.
The copycat versions are made by compounding pharmacies. The formulations aren’t the same as the FDA-approved versions of the drug and haven’t been directly evaluated by the FDA, either. But they’re cheaper than the real thing: $199 a month, compared to the branded version, which can cost more than $1,000 a month without insurance.
Compounding pharmacies can make knockoff versions of branded drugs when they are in shortage, as the GLP-1 drugs — prescribed for diabetes and weight loss — currently are. The FDA has already received reports of adverse events for compounded versions of semaglutide.
Hims & Hers says it “conducted extensive research for over a year” into finding a supplier but does not name the one it chose to partner with. “Over the last year, we have grown in our conviction — based on our medical experts’ evaluation and the strength of our infrastructure — that if done properly, compounded GLP-1s are safe and effective,” the company said in its statement.
Hims & Hers introduced its weight loss program in December 2023, according to an investor presentation. Its weight loss program costs $79 a month and is expected to “deliver $100m+” in 2025. Hims & Hers makes most of its money through subscriptions; more than 90 percent of its revenue is “recurring.” Expanding its number of subscribers is how it plans to grow. GLP-1 weight loss drugs must be taken continuously in order to sustain weight loss; one study has shown that people regain two-thirds of the pounds they lost once they quit semaglutide.
In the first quarter of 2024, the company added “a record 172k net new subscribers,” it said in its shareholder letter. The company has splashed out on TV advertising during NBA and NFL games as well as Keeping Up With the Kardashians and The Bachelorette.
This is a price quote from one of the major PBM’s websites and a Medicare Part D prgm.
The TOP PRICE is for 30 days supply and labeled as IN-STORE. The second price is for a 90-day supply labeled as MAIL ORDER. The mail order – I PRESUME – is the mail order pharmacy owned by the PBM managing the Part D Rx billing/payment.
Generally, mail-order pharmacies have a mandatory 90-day supply of all Rxs they fill. Would a prescriber willingly change the C-II they wrote for 30 days to a 90-day supply?
Would the fact that the mail order pharmacy wants to charge the pt 5-6 times the cost/dose of filling their Rx at a local community pharmacy?
According to GoodRx… the lowest quoted prices were $32 & $67 respectively for the two quantities. Either one of those issues could cause the pt to go without their needed medication. The Prescriber is unwilling to prescribe a 90-day supply and/or the patient can’t afford the PRICE!
There is little question why the PBM industry is trying to run as many pharmacies – especially independent pharmacies – in rural areas. So that they can create an untold number of “pharmacy deserts” so that the PBM industry can “persuade” all these pts with no nearby pharmacies, to utilize their PBM mail-order pharmacies and more profits to their bottom line.
You may have to CLICK TWICE ON THE IMAGE to get it more readable
In healthcare, privacy is paramount. It is an essential component of building trust with patients and, well, protecting patient privacy is also the law.
Or it is supposed to be.
According to charges broughtby the Federal Trade Commission (FTC), the online therapy provider BetterHelp (now a part of Teladoc Health) allegedly used and disclosed sensitive user data — including internet protocol (IP) addresses, email addresses, and information in health questionnaires — to social media giants like Facebook, Pinterest, and Snapchat, among others. In its findings, the FTC said BetterHelp misrepresented its compliancewith the Health Insurance Portability and Accountability Act (HIPAA).
While it remains unclear whether BetterHelp’s actions constituted a direct violation of HIPAA, the allegations in this case are alarming. BetterHelp allegedly disregarded the implicit confidentiality patients believe exists with their therapists, no matter the medium through which care is delivered.
The total value of the refund per consumer? Just under $10 — a fraction of the $260 to $400 average monthly costof care through BetterHelp.
That figure clearly trivializes the potential damage to those affected. Beyond not adequately reimbursing patients financially, $10 does not begin to address the emotional and psychological impact of knowing one’s private data may have been used without consent. That violation may have compounded the hurt and trauma for which these patients sought care in the first place.
The violation also arguably damaged the reputation of all providers, especially those that operate exclusively online. When confidentiality is compromised, and trust is breached, it potentially deters people from seeking essential mental health services.
Is $10 the best BetterHelp could do?
Systemic Issues in Privacy Breaches
The privacy concerns highlighted by the BetterHelp case are not isolated. The industry has seen a surge in data breachesover the last several years.
The recent Change Healthcare cyberattackwas widely publicized, and, perhaps better than any other story, highlighted the fragility of our integrated billing and prescription transmission system for both patients and practitioners. (Side note: UnitedHealth Group may want to use multi-factor authentication
As a result of the Change Healthcare security lapses, nearly 80% of physiciansopens in a new tab or window have faced reimbursement backlogs or lost revenue, and patients have seen delays in procedures and prescriptions. While it appears timely reimbursements were the top-line issue reported in this case, patient privacy concerns should have been at the forefront too, with the House Energy and Commerce Committee finding that patient informationfrom the attack likely made its way onto the dark web.
Similar privacy concerns exist within traditional healthcare settings, particularly involving third-party scheduling software services that have sold patient information.
Privacy concerns are exacerbated by incentives to monetize consumer information. A study published in JAMAin April 2024 found that 96% of hospital websites transmitted user information to third parties such as Meta and Google. It is unclear what Meta, the owner of Facebook and Instagram, does with this information, but similar practices have been suspected to be used to inform health-related advertising
These incidents clearly demonstrate the pressing need for stringent data protection measures across all healthcare platforms, digital and traditional.
Washington Must Enhance Data Protections
The expansion of telehealth has transformed healthcare delivery, making it more accessible and, often, more efficient. But the rapid growth of this sector must not outpace the development of robust safeguards for patient privacy.
The House currently is considering a bipartisan data privacy bill(the American Privacy Rights Act [APRA]), that if approved by the chamber and the Senate and signed into law, would provide a data privacy regime for all sectors of the U.S. economy, including healthcare. More specifically, the bill would give consumers the opportunity to gain access to, correct, and delete any of the personal data companies gather and share about them. While organizations subject to HIPAA would be mostly exempt, they would need to comply with APRA’s data security provisions.
The APRA would also enhance consumer rights when it comes to non-HIPAA-protected information, like search queries and information recorded on mental health apps. Finally, APRA would allow consumers to sue companies that unlawfully transmit or collect covered data. (Maybe they would get more than $10.)
This draft bill is a good start.
Ensuring the security of patient data is a critical ethical obligation. As we continue to navigate the complexities of healthcare in the digital age, it is imperative that all stakeholders in the healthcare marketplace, including regulators, providers, and technology partners, reaffirm their commitment to protecting patient information. This task involves not only adhering to existing laws and regulations, but actively advocating for stronger protections and more transparent practices. It is also essential that patients stay informed and vigilant about their rights and the ways their data is used.
The BetterHelp settlement serves as a stark reminder of the vulnerabilities in telehealth and data security. Patients and livelihoods are at risk. As we embrace the immense promise of technology in healthcare, we must also prioritize the protection of the very individuals we aim to serve, and we must have strong regulatory protections, as well as penalties, for breaches.
The integrity of medicine, particularly mental healthcare, depends on our ability to safeguard patient data.
