Latest news with #21stCenturyCuresAct
Bloomberg
5 days ago
- Health
- Bloomberg
WHOOP CEO Says Its Blood Pressure Tool ‘Follows the Law'
00:00 What's your view that the FDA does not have authority in this moment, your wellness, not medical device? Well, thanks for having me on. You know, you've spent the last three years developing a very innovative feature called Blood Pressure Insights, and this takes our wrist worn wearable alongside a calibration with a cuff and is allowed to provide you with a daily estimate of your blood pressure. And in turn, it also then gives you insights how your blood pressure may be affecting other things in your wellness. This could be sleep, stress, nutrition, a variety of different wellness factors. And the FDA is coming forward saying that they believe that this should be regulated. Now, the 21st Century Cures Act makes it very clear that wellness intended features are not supposed to be regulated by the FDA, and the FDA is intended to actually just regulate medical devices that are diagnosing something. So there's this key question of intended use. And you can see this with other physiological metrics like heart rate monitoring, for example, where Hari monitoring has wellness applications and medical applications. The wellness applications might be things like exercise or stress monitoring or sleep monitoring. And we do all that right. And alternatively, there could be, you know, a diagnosis for AFib, and that would be an example where the say, well, well, that's what the FDA misinterpreted of. Right. But you're a smart guy and you employ lots of smart people. Why not just go through the FDA process in the first place kind of foreseeing that this might come up? Well, you have to understand, there's different use cases, right? One use case for blood pressure is around wellness. And there's other use cases that might be a medical diagnosis. And we're certainly looking at, you know, cleared products as well and a longer term horizon. But we're providing a lot of value today and we're following the law again. The 21st Century Cures Act makes it very clear if a product is intended for a wellness use case, it's not supposed to be regulated by the FDA. So then the fundamental question becomes, does blood pressure have wellness intended use cases? We believe it does, right? There's an avalanche of peer reviewed research that shows that blood pressure, not surprisingly, is influenced and influences other aspects of your well, well, why call it medical grade? Why market it that way? Well, we recently came out with the WOOP five data and the BMJ and a key distinguishing factor between the five data and the M.G. is that the M.G. has a medically cleared feature on it. Now, both of those products have a number of wellness features associated with it. The WU PMG happens to have an EKG monitor as part of that that can detect A-fib. And by the way, we spent two and a half years working with the FDA to have that be a cleared feature. So that is the distinguishing factor between those two hardware's. And I want to be very clear in the app, there's an enormous number of medical disclaimers explaining what is for wellness and what is for medical capabilities. Well, you've said this is a misunderstanding. What happens next? Will you continue to fight the FDA on or in the background? Are you trying to reach some solution? We have a lot of respect for the team and we've engaged with them on a number of different features over the years. We think in this specific case they have it wrong and so we're going to continue engaging with them on it. We've responded to their warning letter outlining how we feel about this and why we think we're following the law and we look forward to continuing to engage with them on it. Well, that must take up head space and ultimately your time. How does that impact your future product roadmap? How does more broadly, the FDA acting this way affect innovation more broadly, do you think? Ultimately, I think that, you know, innovation needs to be able to thrive in the United States. WOOP is one of the first wearables in the world that can measure blood pressure accurately from the wrist. That's a really big deal. And it's also being accepted in 50 other markets around the world. So, you know, we want to make sure that there's policies that are consistent here in the U.S. that really allow companies to innovate and to operate. It's also worth noting, you know, we have a lot of people using this every single day. And overwhelmingly, if you look at the feedback from our members, they absolutely love this feature and they talk about how accurate is and how it's helping them understand their wellness. So we feel like we're on the right side of history and we're going to continue educating the FDA on what we're doing. Well well, I'm very quickly I'm not a we use it, but I'm very conscious that in the Premier League and other international football players, it's it's very in the public conscience. I just wonder like is this a good PR moment for you to fight America's regulator? I think in the long run will be on the right side of history and that maybe in a very short period of time, too. I think that fighting for innovation, fighting for Americans access to health data is the right thing to do. And, you know, I've spent 13 years building this company. When I first started, the idea that you could measure sleep or heart rate accurately from the wrist seemed impossible. And now we're able to do blood pressure accurately from the wrist. That's a really big deal. And I think it should be celebrated as long as there's the right guidelines in place and the right education in place for members to understand how to use. And that's what we've done with this feature, and that's why we're proud of it.
Boston Globe
5 days ago
- Health
- Boston Globe
Whoop there it is: FDA wants to regulate wearable firm's blood pressure tool
Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up But in a response sent Aug. 4, Whoop rejected the FDA's assessment, saying the software didn't meet the definition of a medical device and the company would continue to offer the feature to users. The company, which shared the letter with The Boston Globe, also argued the move went against the goals of the Trump administration. Advertisement 'Seeking to regulate the feature as a medical device also runs counter to the stated policy of the Secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., of 'clearing away regulatory barriers so innovation can thrive,'' Whoop said in the letter. Advertisement Whoop's refusal to comply with the FDA's request is uncommon, legal experts said. The FDA, which oversees the safety of medical devices and pharmaceuticals, is usually the ultimate decider of what comes under its jurisdiction and which devices can be sold to help people manage or treat health conditions. Chris Robertson, a Boston University law professor who teaches FDA law, said any communication from the FDA to a company is typically enough to make the company get in line with federal standards. 'You're playing with fire here,' Robertson said. 'That means that Whoop is taking a real calculated gamble.' Wearable technology sits in a grey area when it comes to regulation. The wearables market, estimated by one market intelligence group to be worth $84 billion in 2024, is rapidly expanding, and companies are racing to add new features that give users unique health measurements. Related : Smart wristbands, watches and rings that assess heart rates don't have to get cleared as medical devices. But Whoop competitors, such as Apple and Fitbit, have sought FDA approval for certain software tools in recent years. The crux of Whoop's argument rests on the 21st Century Cures Act, a 2016 law that exempts wellness software features from the definition of a medical device, so long as those features aren't related to the diagnosis, prevention, or treatment of a disease. Blood Pressure Insights, Whoop said, is only intended to be used as a way to gauge a person's performance, quality of sleep, and stress levels . The FDA, however, has rejected Whoop's characterization of the blood pressure tool. In its letter, the agency said the product qualifies as a medical device because its measurements are 'inherently associated with the diagnosis of a disease or condition,' such as hypertension, or high blood pressure. Advertisement Whoop has registered one of its products with the FDA, securing medical device approval for its Heart Screener tool. That tool measures the heart's electrical activity to alert users to potentially abnormal heart rates and atrial fibrillation, a common type of abnormal heart rhythm. The FDA said it doesn't comment on 'ongoing investigations, compliance matters or enforcement activities except with the company involved.' Related : The confrontation is reminiscent of the clash more than a decade ago between the FDA and the personal genomics platform 23andMe, said health law expert Frances Miller, who also teaches at Boston University. The FDA and 23andMe went back and forth on whether the company's health test — which the company claimed could tell customers their risk of conditions like gallstones, heart disease, or arthritis — constituted a medical device. In 2013, the FDA sent a warning letter to 23andMe much like the one it sent Whoop, and 23andMe ultimately capitulated. But the landscape looks different today, Miller said. The FDA has experienced significant cuts under President Trump, and federal agencies as a whole have lost power. In addition, Kennedy has publicly stated his vision that 'every American is wearing a wearable within four years.' Whether Whoop will win its fight against regulation is unclear, Miller said. 'I could have given you a very confident answer a year and a half ago,' Miller said. 'Not now. They're pushing the envelope.' Marin Wolf can be reached at
Yahoo
20-05-2025
- Health
- Yahoo
The Most Common Kind of Cancer Patient in America Is the One We Study the Least
Sign up for the Slatest to get the most insightful analysis, criticism, and advice out there, delivered to your inbox daily. Former President Joe Biden has been diagnosed with an aggressive form of prostate cancer that has spread to his bones, his office said in a statement on Sunday. The diagnosis occurred last week, following a urinary screening that revealed a small nodule in his prostate, which revealed the aggressive Stage 4 prostate cancer, according to the statement. The office added, 'The cancer appears to be hormone-sensitive which allows for effective management.' Biden released his first statement regarding his diagnosis on Monday. 'Cancer touches us all,' the 82-year-old wrote on X. 'Like so many of you, Jill and I have learned that we are strongest in the broken places. Thank you for lifting us up with love and support.' Biden's cancer diagnosis is equal parts tragic and ironic. It's tragic because a cancer diagnosis is always tragic. It means long treatments that can be painful and debilitating, lots of waiting and worrying, and the very real possibility that you might not survive, even under the best circumstances. The former president will have access to excellent care without fear of medical debt—something not every American can say. But that guarantees very little. On top of that, in 2015 Biden's older son, Beau Biden, died at 46, after being diagnosed with one of the most aggressive types of brain cancer. Biden's experience in supporting and eventually losing his son greatly influenced his decision to spearhead the Beau Biden Cancer Moonshot, a research initiative that aims to cut cancer death rates in half by 2047. The project was initially launched in 2016 under the Obama administration and later reignited in 2022, under then-President Biden. It received $1.8 billion in funding through the bipartisan 21st Century Cures Act to support more than 250 research projects and 70 programs with the goal of supporting patients and their families and ultimately ending cancer for good. But therein lies the irony: The vast majority of cancer trials exclude older patients like Joe Biden, despite the fact that most patients who get cancer are over the age of 65. Although the Food and Drug Administration released guidance around the reignition of the Cancer Moonshot to help the issue, it remains a systemic problem. Cancer can affect anyone, but it disproportionately comes for older people. Roughly 60 percent of all cancer diagnoses and about 70 percent of cancer deaths occur in patients 65 or older. Yet a 2024 study published in the journal BMC Cancer examined 7,747 clinical trials on cancer and found that only 25 percent of cancer trial participants are over 65 years old. A 2019 study in JAMA Oncology found that in clinical trials the median age of participants with common cancers such as breast, prostate, and lung cancer was nearly six and a half years younger than the median age of people actually diagnosed with the disease. Even though prostate cancer trial participants skewed slightly older due to the cancer type, participants were still three and a half years younger than the average prostate cancer patient. There are several factors at play here. For one, a lot of clinical trials have strict criteria to determine who exactly gets to participate in cancer studies. Supriya Mohile is a geriatric oncologist with the University of Rochester Medical Center whose research sheds light on the underrepresentation of older adults in cancer trials. She tells Slate that although studies have gotten better about not restricting on the basis of chronological age, older adults are still underrepresented due to eligibility criteria that favor fitter patients. 'We don't do a good job assessing fitness for older patients with cancer,' Mohile said. 'Sometimes we see older people in the clinic, and one doctor might say, 'Oh, you're 80. You're too old for this clinical trial,' even when they're pretty fit and they don't have a lot of other things going on.' She puts it another way: Clinicians often rely on an 'eyeball test' to assess patients—but that type of appraisal is subjective, imperfect, and likely to vary from clinician to clinician. She highlights the need for more objective measures when determining someone's eligibility for clinical trials like the Comprehensive Geriatric Assessment, which is a tool to evaluate function, psychological status, cognition, and physical strength in older adults. Often, those with complications related to age, including comorbidities and reduced organ function, are excluded from trials. Older folks are also less likely to be able to tolerate experimental treatments, which frequently results in their exclusion. This age disparity is an issue not just for cancer research, but also in other fields, including cardiovascular, neurological, and psychiatric studies. This causes blind spots in our medical systems and treatments, which are designed without older bodies in mind. Clinicians base the drug doses, side effects, and expected outcomes on younger participants—which can result in older patients becoming over- or under-treated, experiencing unexpected side effects, and leaving their doctors guessing as to their care outcomes. Mohile notes that, following the release of the new FDA guidance in 2022 on including more older adults, she worked with a multidisciplinary team that included academics, clinicians, and advocates in the National Cancer Institute and FDA to develop a series of articles that outline best practices to improve recruitment of older adults for clinical trials. However, the recommendations were just that. Age-related disparities in cancer research and health care as a whole remain in place. 'The challenge was that there's no carrot or stick,' Mohile said. She added, 'I don't think it's as much as it needs to be still—and I don't know if that'll change.' Would Biden, at the age of 82, even qualify for the trials funded under his own initiative? Mohile stops short of ruling it out (and notes that an experimental treatment might not be the best course of action for him anyway). Still, the fact is that cancer research is built largely around younger, healthier bodies. Aside from the findings of the research, the trials themselves can be bastions of hope, and enrolling in them can be a last resort for many with cancer—providing access to experimental treatments that give them a fighting chance. When you get turned away from that, it can be devastating, no matter how old you are. This is ageism, pure and simple—and it's a problem in not just medicine but society in general. We devalue older adults. We associate increased age with decline and irrelevance. Older people are seen as a burden rather than members of society who deserve dignity, respect, and attention, just like anyone else. Economic incentives deprioritize the complex, long-term care these folks require—and encourage our willful ignorance of their needs. Yet we have all the more reason to design medicine that actually accommodates the complexities of aging bodies. If most older patients have a comorbidity, then that's not a reason to exclude them from trials—it's the reason to include them. It doesn't matter if it's complicated and expensive. Medicine shouldn't be designed around 'ideal' bodies; it should rise to meet real ones. It's not a stretch to say that the future of society depends on our research on and attention to older adults, including those suffering from multiple ailments at a time. The global population is getting very old, very quickly. Those age 65 and older are the fastest-growing demographic group on Earth, according to the United Nations. In the U.S. alone, that cohort will make up roughly 25 percent of the population by 2060, compared with just 16.8 percent today. It's not a question of if. Aging—and all of the diseases and health complications that come with it—is one of the most complex and impactful issues of the future. The issue isn't going to get any better anytime soon either. President Donald Trump, who is also a geriatric politician who would greatly benefit from research into age-related diseases, has been busy in the first few months of his second term taking a massive knife to health care research. He cut cancer research funding by 31 percent earlier this year and also reduced the budgets for crucial research bodies such as the National Institutes of Health and the National Science Foundation by billions of dollars. This is on top of the pause on all federal research grants, a break that has resulted in widespread disruption and uncertainty for ongoing clinical research. This, like so much of American governance, is wildly out of step with where the world is heading. The dream of the Cancer Moonshot is a future where cancer research reflects its patients, and not what saves the most money. It takes courage to rethink whom our science and health care is designed for—and whom we consider worth saving. However, that is accomplished not just by offering FDA guidance and recommendations—especially because, as we've seen, so much of it can be undone by the whims of the executive branch. What is needed, Mohile explains, is an act of Congress that would make it a requirement to take older adults into account when designing treatments. She points to bills that have been passed by Congress, such as the 2017 RACE for Children Act and those that require pediatric testing of cancer drugs. 'There's not a congressional mandate for older adults,' she noted. 'It's not required.' So if the Moonshot and other large-scale efforts really want to adhere to their moral promise of eliminating cancer, they should actively center the kind of person most likely to face the disease: somebody like Joe Biden.
Axios
19-05-2025
- Health
- Axios
What to know about Joe Biden's Cancer Moonshot
Former President Biden is being praised following his prostate cancer diagnosis for his efforts in spearheading Cancer Moonshot, an initiative that's designed to improve treatments and combat rates of the disease. The big picture: Former President Obama, who appointed Biden to lead the drive a year on from his son Beau Biden's 2015 death from brain cancer, said after it was announced that his VP has an aggressive for of cancer that's spread to his bones: "Nobody has done more to find breakthrough treatments for cancer in all its forms than Joe." State of play: The Obama White House announced Cancer Moonshot in 2016 "to eliminate cancer as we know it" and kickstarted the national program with $1 billion in research funding. It became known as the Beau Biden Cancer Moonshot Initiative. Biden relaunched Cancer Moonshot in 2022 with the goals of reducing the age-adjusted death rate from cancer by 50% over 25 years and "making a decade's worth of progress in cancer prevention, diagnosis, and treatment in five years," per a National Cancer Institute post. Tens of millions in funding has gone toward cancer programs since then, including $150 million last year to develop technologies that the Biden White House said would help with tumor-removal surgeries. Cancer Moonshot has "supported 250 research projects and more than 70 programs and consortia," according to a National Cancer Institute (NCI) post that was last updated in April. What he's saying: "After Beau died, I literally visited every major cancer research facility in the world — seven of them around the world. I wanted to see what was possible, and I did," then-President Biden said last September, according to recorded remarks of his speech before world leaders and scientists to announce the Quad Cancer Moonshot in his home state of Delaware. "They're making significant progress," Biden said after the Quad heads of state from the U.S., Australia, Japan and India committed to the drive. "And it's not just because it's personal — this —but it's because it's possible," he added. "Our goal is to team up, end cancer around the world, and start — starting with cervical cancer. I know it may sound unrealistic, but it's not." How it worked: "Funded through the 21st Century Cures Act, the Cancer Moonshot brought together patients, advocates, researchers, and clinicians dedicated to utilizing resources across the government, academia, and the private sector," per the NCI. Using a panel of experts' broad recommendations as a guide, NCI said it "identified goals that would reflect this guidance and accelerate discovery, increase collaboration, and expand data sharing across the cancer community." Among the accomplishments the NCI lists the Cancer Moonshot achieving are expanding prevention drives, developing "new enabling cancer technologies to characterize tumors and test therapies" and intensifying research into the leading causes of childhood cancers.
Los Angeles Times
09-05-2025
- Health
- Los Angeles Times
How Healthcare Systems Are Strengthening EHR Security
Electronic Health Record (EHR) systems are the backbone of modern healthcare. With the widespread EHR adoption driven by legislation like the HITECH Act and 21st Century Cures Act, providers globally are using them more than ever. They make it easier for clinicians to access patient data, coordinate care and improve outcomes. But with those benefits comes a big question—how do we keep that data safe? With cyber threats increasing and sensitive health info on the line, EHR security is more important than ever. Luckily providers are using a mix of old and new to protect patient privacy and trust. Electronic Health Records (EHRs) are a digital version of a patient's medical history including demographics, medical and treatment history, lab results, and clinical notes. EHRs have changed the way providers manage patient data, making care better and more efficient. With EHRs providers can access patient info quickly and easily reducing the risk of medical errors and improving patient outcomes. EHRs have streamlined clinical workflows for healthcare organizations allowing for more coordinated and effective care. By centralizing patient data EHRs allow providers to make informed decisions leading to better health records management and improved treatment outcomes. The benefits of EHR systems are many from better patient care to increased operational efficiency and better data security. EHRs give providers immediate access to patient information so they can make informed decisions about patient care. This quick access to data reduces the risk of medical errors and patient safety. EHRs also minimize administrative tasks like paperwork and data entry so providers can spend more time on patient care. EHRs make data more accessible and shareable among providers leading to better collaboration and care. Plus EHRs have been shown to improve health outcomes by providing a complete picture of a patient's medical history and treatment history which is critical for accurate diagnosis and treatment planning. Access Control: One of the first lines of defense in EHR systems is limiting who can get in. Access control—especially when fine-tuned by roles and responsibilities—helps prevent unauthorized entry. A cross-country study found that strong access control on workstations was associated with a 44% lower chance of technical interoperability issues [6]. That's not just about safety—it also keeps the system running smoothly. Encryption and Cryptography: Data encryption scrambles sensitive information so that only authorized users can make sense of it. Healthcare systems typically use a combination of symmetric (shared key) and asymmetric (public/private key) encryption to protect records. Think of it like sealing a letter in a locked box—only the right key can open it. Digital Signatures: Digital signatures ensure that EHR data hasn't been tampered with. This helps prove authenticity and prevents repudiation, meaning users can't deny their actions later. Role-Based Access Control (RBAC): RBAC assigns system privileges based on job roles. For instance, a nurse may only see certain patient data, while a physician has broader access. This targeted limitation reduces exposure to data breaches and keeps confidential information in the right hands [2]. Clinical Decision Support: Clinical decision support within EHR systems enhances security and functionality by automating the monitoring of clinical events. It improves care efficiency, reduces medical errors and provides healthcare professionals with necessary data insights and alerts during patient care. Staff Training: Even the most secure system can be undone by human error. That's why continuous education around privacy, security practices and cyber hygiene is key. Well-trained staff are less likely to fall for phishing scams or mishandle data [3]. Regulatory Compliance: To stay aligned with legal and ethical standards, healthcare organizations must comply with data privacy regulations like HIPAA in the US and the European Data Protection Directive 95/46/EC [2]. These laws help guide how patient information is handled and shared across systems. Plus legal limitations under regulations like HIPAA can restrict the sharing of certain types of demographic data which can impede the development of multi-source electronic health record (EHR)-based registries. [4] Health data management is a critical component of EHR systems, involving the collection, storage and analysis of patient data. EHRs store a vast amount of data including demographic information, medical history, laboratory test results and clinical notes. This data is essential for clinical decision making, patient care and health outcomes [5]. Effective health data management ensures the accuracy, completeness and security of patient data which is vital for the integrity of the healthcare system. EHR systems must be designed to maintain the confidentiality, integrity and availability of patient data while providing healthcare providers with access to the information they need. By ensuring patient data is accurate and available EHR systems support high quality care and better health outcomes. Health Information Exchange (HIE) is the process of sharing patient data between healthcare providers, organizations and systems. HIE is critical to ensure patient data is available to healthcare providers when and where it is needed to improve the quality and efficiency of care. EHR systems play a key role in HIE by enabling the secure and electronic sharing of patient data. [10] HIE can take many forms including direct messaging, query-based exchange and document-based exchange. Implementation of HIE has been shown to improve patient care by providing healthcare providers with a more complete view of a patient's medical history, reducing medical errors and improving health outcomes. By facilitating data sharing HIE ensures healthcare providers have the information they need to deliver the best possible care. [9] Distributed Ledger Technology (DLT): DLT including blockchain introduces a decentralized and tamper-proof way of handling health data. Since each transaction (or data entry) is stored across a network of computers it's almost impossible to alter records without leaving a trace. According to Healthcare (Basel) this makes blockchain a strong candidate for EHR security [1]. However high implementation costs and technical complexities remain barriers to adoption. Advanced Encryption Techniques: A fascinating approach involves combining hyperchaos and image embedding. One study demonstrated a technique that encrypts EHRs and hides them in images – kind of like digital steganography. With a high payload capacity of 0.75 bits per pixel and a strong signal-to-noise ratio it offers promise for securely sharing data without making it obvious [7]. EHRChain Framework for Electronic Health Records: This dual-blockchain model uses both Hyperledger Sawtooth and InterPlanetary File System (IPFS) to distribute EHR data across multiple nodes. The EHRChain framework improves both security and accessibility and could solve some of the core interoperability issues in current systems [11]. Technology is only half the equation—user trust is just as important. A qualitative study looked at how patients and providers felt about cloud-based, privacy-focused EHR systems. Users wanted control over their own data and needed to feel confident their information wouldn't be misused or exposed [8]. Accurate patient identification is key to maintaining trust and data integrity. Trust, transparency and usability were the make-or-break factors for adoption. The future of EHR systems is bright with many developments on the horizon. One of the key trends is the increasing adoption of cloud-based EHR systems which offer more flexibility, scalability and security. Cloud-based solutions allow healthcare providers to access patient data from anywhere and provide more coordinated and efficient care. Another big trend is the integration of artificial intelligence (AI) and machine learning (ML) into EHR systems. These technologies can analyze patient data to provide valuable insights to healthcare providers. Mobile devices and patient portals are also becoming more prevalent allowing patients to take a more active role in their care. Blockchain is being explored to enhance patient data security. As EHR systems evolve they will play a bigger role in improving patient care, health outcomes and reducing healthcare costs. Protecting patient data in EHR systems isn't just about firewalls or encrypting files—it's about building a security culture from the ground up. Traditional safeguards like RBAC and encryption will continue to play a critical role but emerging tools like blockchain and hyperchaotic encryption may redefine what's possible. Ultimately the success of any EHR security system depends not just on the tech but on its usability and the trust it earns from the people who use it. [1] Carlos Ferreira, J., Elvas, L. B., Correia, R., & Mascarenhas, M. (2024). Enhancing EHR Interoperability and Security through Distributed Ledger Technology: A Review. Healthcare (Basel, Switzerland), 12(19), 1967. [2] Fernández-Alemán, J. L., Señor, I. C., Lozoya, P. Á., & Toval, A. (2013). Security and privacy in electronic health records: a systematic literature review. Journal of biomedical informatics, 46(3), 541–562. [3] Basil, N. N., Ambe, S., Ekhator, C., & Fonkem, E. (2022). Health Records Database and Inherent Security Concerns: A Review of the Literature. Cureus, 14(10), e30168. [4] Rezaeibagha, F., Win, K. T., & Susilo, W. (2015). A systematic literature review on security and privacy of electronic health record systems: technical perspectives. Health information management : journal of the Health Information Management Association of Australia, 44(3), 23–38. [5] Kruse, C. S., Smith, B., Vanderlinden, H., & Nealand, A. (2017). Security Techniques for the Electronic Health Records. Journal of medical systems, 41(8), 127. [6] Shrivastava, U., Song, J., Han, B. T., & Dietzman, D. (2021). Do data security measures, privacy regulations, and communication standards impact the interoperability of patient health information? A cross-country investigation. International journal of medical informatics, 148, 104401. [7] Aljuaid, H., & Parah, S. A. (2021). Secure Patient Data Transfer Using Information Embedding and Hyperchaos. Sensors (Basel, Switzerland), 21(1), 282. [8] Alaqra, A. S., Fischer-Hübner, S., & Framner, E. (2018). Enhancing Privacy Controls for Patients via a Selective Authentic Electronic Health Record Exchange Service: Qualitative Study of Perspectives by Medical Professionals and Patients. Journal of medical Internet research, 20(12), e10954. [9] Middleton, B., Bloomrosen, M., Dente, M. A., Hashmat, B., Koppel, R., Overhage, J. M., Payne, T. H., Rosenbloom, S. T., Weaver, C., Zhang, J., & American Medical Informatics Association (2013). Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA. Journal of the American Medical Informatics Association : JAMIA, 20(e1), e2–e8. [10] Li, E., Clarke, J., Neves, A. L., Ashrafian, H., & Darzi, A. (2021). Electronic Health Records, Interoperability and Patient Safety in Health Systems of High-income [7] Countries: A Systematic Review Protocol. BMJ open, 11(7), e044941. [11] Pilares, I. C. A., Azam, S., Akbulut, S., Jonkman, M., & Shanmugam, B. (2022). Addressing the Challenges of Electronic Health Records Using Blockchain and IPFS. Sensors (Basel, Switzerland), 22(11), 4032.
