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Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials

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Collaboration brings the next generation of cutting-edge ECG technology to trial participants’ homes, enabling accurate cardiac safety trial measurements with fewer site visits.

  • Clario and AliveCor provide a new trial-participant-friendly solution for cutting-edge, at-home data collection with privacy protection, instrumental in situations where traditional 12-lead ECG cannot be collected.
  • The KardiaRx app is the next-generation, comprehensive and customized solution that allows trial participants to easily collect medical-grade six-lead ECG readings from their own homes, helping facilitate recruitment and improve retention rates.
  • The KardiaRx app resolves PII issues and associated sponsor risk with the commercial-use Kardia app and features a simplified user workflow to help avoid protocol deviations.

PHILADELPHIA, Aug. 15, 2023 /PRNewswire/ — Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, today announced an expansion to its collaboration with AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology. This collaboration will enable trial participants to collect medical-grade six-lead ECG readings in the comfort of their own homes through KardiaRx, a clinical-trial-focused app. This technology enables pharmaceutical and biotech customers to consider decentralized and hybrid clinical trial strategies in study protocols that would have otherwise been limited to on-site evaluations.

AliveCor’s KardiaRx app works with their FDA-cleared KardiaMobile® 6L, the most clinically validated personal ECG solution in the world, a wireless and user-friendly device that requires minimal training to learn how to use. The companion KardiaRx app has been integrated into Clario’s clinical trial platform, which allows site personnel to provide trial participants with a secure connection code for initial setup and login. This ensures high-quality ECG data is collected seamlessly from the trial participants, while also protecting trial-participant data and eliminating the need for participants to create a new account or provide personally identifiable information.

“Our partnership with AliveCor is a game-changer for at-home ECG data collection,” said Ellen Street, EVP Cardiac Safety & Respiratory at Clario. “Combining Clario’s scientific expertise and 50 years of experience in cardiac safety with AliveCor’s focus on customizable app functionality will mean pharmaceutical and biotech customers now have new opportunities to incorporate decentralized or hybrid strategies into their study protocol. This not only enables high-quality data collection but also offers a more diverse pool for recruitment and reduced site visits, and ultimately leads to more successful trials.” 

“Putting FDA-cleared ECG measurement technology in participants’ hands has helped make decentralized clinical trials a reality, and our partnership with Clario brings this capability to even more companies developing the innovative and life-saving therapies of tomorrow,” said Patti Baran, SVP of AliveCor. “Applying our remote monitoring solutions to clinical research advances our vision of becoming the premier provider of end-to-end care for participants when they are not in front of a physician.”

For more information about AliveCor’s KardiaRx app capabilities, please go to Clario.com.

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About Clario

Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s global team of science, technology and operational experts have helped deliver over 24,000 trials and contributed to over 500 FDA and EMEA new drug approvals involving more than five million participants in 120 countries. Our innovation has been transforming clinical trials for 50 years.

For more information, visit Clario.com or follow us on LinkedIn and Twitter.

About AliveCor

AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. Kardia is the first AI-enabled platform to aid participants and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor’s enterprise platform allows third-party providers to manage their participants’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately-held company headquartered in Mountain View, Calif. “Consumer” or “Personal” ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.

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Clario Media Contact
Duncan Cantor
[email protected]

KardiaMobile 6L 6-lead EKG view

 

AliveCor

Logo – https://mma.prnewswire.com/media/1677749/Clario_Logo.jpg
Photo – https://mma.prnewswire.com/media/2185049/KardiaMobile_6L_6_lead_EKG_view__002.jpg
Photo – https://mma.prnewswire.com/media/2185050/AC_logo_for_press_release_linkedin_preview.jpg 

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Ethereum ETFs Aren’t Blockchain But Is A Revolutionary Tech: Top 6 Amazing Reasons To Invest In Them

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The financial landscape is rapidly evolving, with the integration of blockchain technology and cryptocurrencies becoming more prominent. Among these, Ethereum ETFs (Exchange-Traded Funds) have emerged as a significant investment vehicle, offering exposure to the Ethereum blockchain’s native cryptocurrency, Ether (ETH), without requiring direct ownership. However, it’s crucial to understand that Ethereum ETFs are distinct from the blockchain itself and serve different purposes in the investment world.

Understanding Ethereum and ETFs

Ethereum: A decentralized platform that enables the creation and execution of smart contracts and decentralized applications (dApps). It operates using its cryptocurrency, Ether (ETH), which fuels the network.

ETF (Exchange-Traded Fund): A type of investment fund that holds a collection of assets and is traded on stock exchanges. ETFs can include various asset classes, such as stocks, commodities, or bonds.

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Ethereum ETFs: The Intersection of Traditional Finance and Cryptocurrency

An Ethereum ETF provides a way for investors to gain exposure to the price movements of Ether without directly purchasing the cryptocurrency. This is achieved through an ETF structure, where the fund holds assets linked to the value of Ether, and investors can buy shares of the ETF on traditional stock exchanges.

Key Features of Ethereum ETFs:

  1. Indirect Exposure: Investors gain exposure to Ether’s price changes without needing to manage or store the cryptocurrency themselves.
  2. Regulatory Compliance: Unlike the relatively unregulated cryptocurrency market, ETFs operate under the oversight of financial regulators, offering a layer of investor protection.
  3. Accessibility: Ethereum ETFs are available through traditional brokerage platforms, making them accessible to a broader range of investors.

Why Invest in an Ethereum ETF?

  1. Diversification: Including an Ethereum ETF in a portfolio can provide exposure to the cryptocurrency market, potentially enhancing diversification beyond traditional assets.
  2. Convenience and Familiarity: ETFs are a familiar investment product, simplifying the process of investing in cryptocurrencies.
  3. Professional Management: ETF managers handle the investment decisions, including the buying and selling of assets, which can be advantageous for those less familiar with the cryptocurrency space.
  4. Regulatory Oversight: ETFs are subject to regulatory scrutiny, potentially offering more safety and transparency compared to direct cryptocurrency investments.
  5. Potential for Growth: As the cryptocurrency market grows, ETFs linked to assets like Ether may benefit from rising prices.

Key Differences Between Ethereum and Ethereum ETFs

While both are related to the Ethereum blockchain, Ethereum itself and Ethereum ETFs represent different forms of investment:

  • Ethereum (ETH):
    • Direct ownership of the cryptocurrency.
    • Full exposure to Ethereum’s features, including staking and network participation.
    • Traded on cryptocurrency exchanges.
    • Highly volatile and largely unregulated.
  • Ethereum ETF:
    • Indirect exposure through shares representing Ether’s value.
    • Traded on traditional stock exchanges under regulatory oversight.
    • Offers a more stable and familiar investment structure.
    • Typically lower volatility compared to direct cryptocurrency ownership.

Future Considerations for Ethereum ETFs

The approval and launch of Ethereum ETFs mark a significant milestone in bringing cryptocurrencies closer to mainstream finance. They offer a convenient and regulated means for investors to gain exposure to the growing digital assets market. However, they also come with limitations, such as not allowing direct participation in the Ethereum ecosystem’s innovations, like dApps and smart contracts.

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As the market evolves, we may see more sophisticated financial products that better capture the full potential of the Ethereum ecosystem. For now, Ethereum ETFs provide a balanced option for those interested in cryptocurrency exposure within the framework of traditional finance.

In conclusion, while Ethereum ETFs offer a gateway into the world of digital assets, they should be viewed as complementary to, rather than a replacement for, direct investment in the underlying blockchain technologies. Investors should carefully consider their investment goals, risk tolerance, and the unique attributes of both Ethereum and Ethereum ETFs when making investment decisions.

Source: blockchainmagazine.net

The post Ethereum ETFs Aren’t Blockchain But Is A Revolutionary Tech: Top 6 Amazing Reasons To Invest In Them appeared first on HIPTHER Alerts.

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Nexo Reaffirms Commitment to Data Protection with SOC 3 and SOC 2 Compliance

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Nexo, a leading institution in the digital assets industry, has reinforced its commitment to data security by renewing its SOC 2 Type 2 audit and attaining a new SOC 3 Type 2 assessment without any exceptions. This rigorous audit process, conducted by A-LIGN, a respected independent auditor specializing in security compliance, confirms Nexo’s adherence to stringent Trust Service Criteria for Security and Confidentiality.

Key Achievements and Certifications

  1. SOC 2 and SOC 3 Compliance:
    • SOC 2 Type 2: This audit evaluates and reports on the effectiveness of an organization’s controls over data security, particularly focusing on the confidentiality, integrity, and availability of systems and data.
    • SOC 3 Type 2: This public-facing report provides a summary of SOC 2 findings, offering assurance to customers and stakeholders about the robustness of Nexo’s data security practices.
  2. Additional Trust Service Criteria:
    • Nexo expanded the scope of these audits to include Confidentiality, showcasing a deep commitment to protecting user data.
  3. Security Certifications:
    • The company also adheres to the CCSS Level 3 Cryptocurrency Security Standard, and holds ISO 27001, ISO 27017, and ISO 27018 certifications, awarded by RINA. These certifications are benchmarks for security management and data privacy.
  4. CSA STAR Level 1 Certification:
    • This certification demonstrates Nexo’s adherence to best practices in cloud security, further solidifying its position as a trusted partner in the digital assets sector.

Impact on Customers and Industry Standards

Nexo’s rigorous approach to data protection and compliance sets a high standard in the digital assets industry. By achieving these certifications, Nexo provides its over 7 million users across more than 200 jurisdictions with confidence in the security of their data. These achievements not only emphasize the company’s dedication to maintaining top-tier security standards but also highlight its proactive stance in fostering trust and transparency in digital asset management.

Nexo’s Broader Mission

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As a premier institution for digital assets, Nexo offers a comprehensive suite of services, including advanced trading solutions, liquidity aggregation, and tax-efficient credit lines backed by digital assets. Since its inception, the company has processed over $130 billion, showcasing its significant impact and reliability in the global market.

In summary, Nexo’s successful completion of SOC 2 and SOC 3 audits, along with its comprehensive suite of certifications, underscores its commitment to the highest standards of data security and operational integrity. This dedication positions Nexo as a leader in the digital assets space, offering unparalleled security and peace of mind to its users.

Source: blockchainreporter.net

The post Nexo Reaffirms Commitment to Data Protection with SOC 3 and SOC 2 Compliance appeared first on HIPTHER Alerts.

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Marshall Becomes First US Senator to Walk from Controversial Crypto Bill He Co-Sponsored

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Republican Senator Roger Marshall has withdrawn his support for the Digital Asset Anti-Money Laundering Act of 2023, a controversial bill he initially co-sponsored with Senator Elizabeth Warren and others. This bill, reintroduced in the Senate on July 27, 2023, aimed to bring the cryptocurrency industry into alignment with existing anti-money laundering (AML) and counter-terrorism financing (CTF) laws.

Key Provisions of the Bill

The legislation proposed stringent regulations on digital asset providers, including unhosted wallet providers, miners, and validators, by classifying them as financial institutions under the Bank Secrecy Act (BSA). It mandated these entities to adhere to BSA compliance requirements, which include extensive reporting and monitoring responsibilities. Additionally, the bill called for the Financial Crimes Enforcement Network (FinCEN) to establish regulations for reporting significant foreign digital asset holdings and to create compliance measures to address risks associated with anonymity-enhancing technologies.

Senator Marshall’s Shift

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Marshall’s withdrawal from the bill comes as a surprise, particularly given his earlier criticisms of cryptocurrencies, which he has described as a “threat to national security.” This includes concerns over stablecoins like Tether potentially facilitating illegal activities and circumventing U.S. sanctions. Despite his earlier stance, Marshall’s departure from the legislation suggests a reconsideration of the bill’s implications or an alignment with broader political and industry perspectives on cryptocurrency regulation. His office has not provided a comment on the reasons for his withdrawal.

Political and Industry Reactions

The bill had garnered significant bipartisan support, with 18 co-sponsors, reflecting a broader concern in Congress over regulating the rapidly growing cryptocurrency market. However, it has also faced criticism for potentially imposing impractical compliance burdens that could stifle innovation and push crypto activities offshore. Critics argue that the bill’s stringent requirements could inadvertently drive users toward unregulated platforms, thereby undermining its intent to enhance security and regulatory oversight.

Broader Context

The withdrawal comes at a time when cryptocurrency regulation is a highly contentious issue in U.S. politics. Former President Donald Trump has promised to relax crypto regulations if elected, contrasting with the current administration’s more stringent stance. Under President Joe Biden, the Securities and Exchange Commission (SEC) and other regulatory bodies, led by figures like Gary Gensler, have taken a more rigorous approach to regulating the sector, which has drawn criticism for being overly restrictive.

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Senator Marshall’s decision to step back from the Digital Asset Anti-Money Laundering Act reflects the complex and evolving nature of cryptocurrency regulation in the U.S. While the bill seeks to bring greater oversight and security to the crypto industry, it also raises concerns about regulatory overreach and its potential negative impact on innovation and privacy. As the debate continues, the U.S. legislative and regulatory landscape for cryptocurrencies remains in flux, balancing the need for security with the desire to foster technological innovation.

Source: decrypt.co

The post Marshall Becomes First US Senator to Walk from Controversial Crypto Bill He Co-Sponsored appeared first on HIPTHER Alerts.

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