21st Century Cures Act

USQHIN Announces Intention to Become a Qualified Health Information Network

Retrieved on:

Wednesday, November 15, 2023

The 21st Century Cures Act, signed by President Obama in 2016, calls on the Office of the National Coordinator for Health Information Technology's (ONC) to "develop or support a trusted exchange framework, including a common agreement among health information networks nationally."

Key Points:

The 21st Century Cures Act, signed by President Obama in 2016, calls on the Office of the National Coordinator for Health Information Technology's (ONC) to "develop or support a trusted exchange framework, including a common agreement among health information networks nationally."
Under TEFCA, QHINs will create a secure and trusted network of networks that will facilitate a flow of information vital to advancing interoperability.
The exchange purposes include Treatment, Payment, Health Care Operations, Public Health, Benefits Determination, and Individual Access Services.
There are currently seven “Candidate QHINS,” including: CommonWell Health Alliance, eHealth Exchange, Epic, Health Gorilla, Kno2, KONZA National Network and MedAllies.

Atsena Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ATSN-101 Gene Therapy for GUCY2D-associated Leber Congenital Amaurosis (LCA1)

Retrieved on:

Tuesday, November 14, 2023

Leber congenital amaurosis, Visual impairment, Food, Hope, Therapy, Paratriathlon, BLA, 21st Century Cures Act, Disease, Patient, FDA, MBA, Drug development, Pharmaceutical industry

DURHAM, N.C., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATSN-101, the company’s lead investigational gene therapy for patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). RMAT designation was granted based on positive 6-month efficacy data from the company’s ongoing Phase I/II clinical trial of ATSN-101.

Key Points:

DURHAM, N.C., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATSN-101, the company’s lead investigational gene therapy for patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1).
RMAT designation was granted based on positive 6-month efficacy data from the company’s ongoing Phase I/II clinical trial of ATSN-101.
"RMAT designation is encouraging recognition of the potential of ATSN-101 to be an important treatment and provides hope to children and adults affected by LCA1."
Atsena has also received orphan drug designation from the FDA for ATSN-101 for the treatment of LCA1.

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis

Retrieved on:

Thursday, November 9, 2023

NDA, Osteoporosis, Woman, Food, Type, PTH, Risk, Patient, Fracture, BMD, FDA, 21st Century Cures Act, Teriparatide, Biomarker, Society, SABRE, Medical imaging, Entera

“This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.

Key Points:

“This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.
We would like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team for its significant contributions and for furthering this key initiative with the FDA,” said Miranda Toledano, Chief Executive Officer of Entera.
“The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.

eClinicalWorks Announces Intent to Become a Qualified Health Information Network and Further Enhance Nationwide Interoperability

Retrieved on:

Tuesday, December 12, 2023

Networks, Health, Practice Management, Technology, Software, EHR, Policy, Organization, ONC, 21st Century Cures Act, Ambulatory care, Patient, PRISMA, RCE, Common, Nursing, Asset management

eClinicalWorks® , the largest ambulatory cloud EHR, today announced its intent to become a Qualified Health Information Network™ (QHIN™) under the Trusted Exchange Framework and Common AgreementSM (TEFCASM) to advance its commitment to nationwide interoperability.

Key Points:

eClinicalWorks® , the largest ambulatory cloud EHR, today announced its intent to become a Qualified Health Information Network™ (QHIN™) under the Trusted Exchange Framework and Common AgreementSM (TEFCASM) to advance its commitment to nationwide interoperability.
eClinicalWorks has an established interoperability infrastructure that connects thousands of eClinicalWorks provider organizations to the Carequality Interoperability Framework and the Commonwell Health Alliance, exchanging more than 200 million clinical records each month.
In January 2022, the Office of National Coordinator for Health Information Technology (ONC) and the Recognized Coordinating Entity® (RCE™), The Sequoia Project, published TEFCA under the 21st Century Cures Act.
“eClinicalWorks is thrilled to formally seek the Qualified Health Information Network designation under the 21st Century Cures Act to further enhance health data exchange for healthcare providers, public health organizations, payers, patients, and all other healthcare stakeholders,” said Girish Navani, CEO and cofounder of eClinicalWorks.

Survey Reveals Only 36% of Healthcare Organizations are Prepared to Meet the Requirements of the 21st Century Cures Act

Retrieved on:

Tuesday, December 12, 2023

The 21st Century Cures Act set standards for the secure and frictionless exchange of data among payers, providers and consumers, including the establishment of an information-blocking rule that was finalized earlier this year.

Key Points:

The 21st Century Cures Act set standards for the secure and frictionless exchange of data among payers, providers and consumers, including the establishment of an information-blocking rule that was finalized earlier this year.
Only 41% of respondents report being able to completely comply with the info-blocking rules set forth in the Cures Act.
“The information blocking rules in the 21st Century Cures Act will also significantly raise the amount of data that flows between organizations within the healthcare industry.
Two thirds of healthcare organizations are not completely confident in their data management infrastructure’s ability to protect the integrity of patient data.

Surescripts Health Information Network Submits Application to Become a Qualified Health Information Network

Retrieved on:

Monday, November 13, 2023

Surescripts®, the nation’s leading health information network, has applied to become a Qualified Health Information Network ( QHIN ), through its subsidiary Surescripts Health Information Network LLC™ , furthering its commitment to the Trusted Exchange Framework and Common Agreement ( TEFCA ) and advancing interoperability to benefit all participants in the Surescripts Network Alliance and the patients they serve.

Key Points:

Surescripts®, the nation’s leading health information network, has applied to become a Qualified Health Information Network ( QHIN ), through its subsidiary Surescripts Health Information Network LLC™ , furthering its commitment to the Trusted Exchange Framework and Common Agreement ( TEFCA ) and advancing interoperability to benefit all participants in the Surescripts Network Alliance and the patients they serve.
“Surescripts is delivering interoperability that empowers clinicians, alleviating some of the most frustrating burdens they face today,” said Frank Harvey, Chief Executive Officer of Surescripts.
Watch: Justin McMartin, product manager at Surescripts, shares what becoming a QHIN will mean for Surescripts Network Alliance partners and the patients they serve.
Surescripts has moved forward in the process of becoming a QHIN by Surescripts Health Information Network LLC submitting its application for review by The Sequoia Project , the Recognized Coordinating Entity ( RCE ) designated by the Office of the National Coordinator for Health Information Technology ( ONC ).

Boomerang Ventures Co-leads $1M Pre-Seed Investment in Primary Record, Mobile Health App Simplifying Health Data for Families

Retrieved on:

Tuesday, December 12, 2023

Communication, Medicare, RN, Family, Prevalence, Research, 21st Century Cures Act, Cryptocurrency

Completed in October 2023, the investment marks a milestone for Primary Record, securing $1M and a Venture Capital Investment tax credit of 30%.

Key Points:

Completed in October 2023, the investment marks a milestone for Primary Record, securing $1M and a Venture Capital Investment tax credit of 30%.
Primary Record enhances the family experience of navigating healthcare through its secure mobile health app that consolidates personal health data, simplifying communication and sharing to improve care coordination while reducing costs.
"Primary Record was born from the idea that families should have the tools to own and share their health information.
Primary Record's mobile app launched on December 1, 2023, initially focused on end-users, families, and community partners.

Cloudticity and BEYOND HC LLC announce HITRUST Accelerator offering available in AWS Marketplace

Retrieved on:

Tuesday, November 28, 2023

GSCA, Organization, Amazon, R2, Partner, APN, HITRUST, Individual shared responsibility provision, Amazon Web Services, 21st Century Cures Act, Health, Common, Certification, AWS, Face, Online shopping

SEATTLE, Nov. 28, 2023 /PRNewswire-PRWeb/ -- Cloudticity, an Amazon Web Services (AWS) Partner Network (APN) Premier Tier Services Partner and healthcare managed cloud provider, and BEYOND HC LLC, a leading HITRUST assessor organization, have released a joint HITRUST Accelerator Bundle that is now available in AWS Marketplace, as part of the AWS Global Security & Compliance Acceleration (GSCA) Program. AWS customers seeking HITRUST certification can gain efficiencies and streamline their certification efforts through HITRUST's Shared Responsibility and Inheritance Model. Together, Cloudticity and BEYOND HC LLC can help AWS customers fully or partially inherit up to 425 controls. This offer is now easily accessed in AWS Marketplace.

Key Points:

Cloudticity, an Amazon Web Services (AWS) Partner Network (APN) Premier Tier Services Partner and healthcare managed cloud provider, and BEYOND HC LLC, a leading HITRUST assessor organization, have released a joint HITRUST Accelerator Bundle that is now available in AWS Marketplace, as part of the AWS Global Security & Compliance Acceleration (GSCA) Program.
Together, Cloudticity and BEYOND HC LLC can help AWS customers fully or partially inherit up to 425 controls.
SEATTLE, Nov. 28, 2023 /PRNewswire-PRWeb/ -- Cloudticity, an Amazon Web Services (AWS) Partner Network (APN) Premier Tier Services Partner and healthcare managed cloud provider, and BEYOND HC LLC, a leading HITRUST assessor organization, have released a joint HITRUST Accelerator Bundle that is now available in AWS Marketplace, as part of the AWS Global Security & Compliance Acceleration (GSCA) Program.
Together, Cloudticity and BEYOND HC LLC can help AWS customers fully or partially inherit up to 425 controls.

Medweb Launches MedwebX, Transforming Secure Data Exchange and Sharing for Healthcare

Retrieved on:

Monday, November 20, 2023

SAN FRANCISCO, Nov. 20, 2023 /PRNewswire-PRWeb/ -- Medweb, a leading innovator in medical imaging technology, today announced MedwebX, a comprehensive and streamlined solution designed to transform the way medical facilities securely share data - including imaging, studies and reports.

Key Points:

"Medweb is ushering in a new era of healthcare data exchange and today's MedwebX launch is a pivotal solution that is helping to redefine the standards of data sharing and integration," said Pete Kilcommons, CEO, Medweb.
"In simplest terms, MedwebX is a way for physicians and healthcare workers to seamlessly share data across networks that is HIPAA compliant," said Pete Killcommons, CEO, Medweb.
"Medweb is ushering in a new era of healthcare data exchange and today's MedwebX launch is a pivotal solution that is helping to redefine the standards of data sharing and integration," added Kilcommons.
"With a focus on interoperability, reduced complexity, and extended PACS lifespan, MedwebX will help foster streamlined connectivity within the healthcare community and take the complexities out of healthcare data sharing."

Florida Department of Children and Families Chooses Juno EHR from Juno Health

Retrieved on:

Thursday, November 16, 2023

JUNO BEACH, Fla., Nov. 16, 2023 /PRNewswire-PRWeb/ -- Juno Health, the commercial division of DSS, Inc., has announced that the Florida Department of Children and Families (DCF) has chosen Juno EHR as its electronic health record (EHR) for Florida State Hospital (FSH) in Chattahoochee, FL. DCF's stated vision for this implementation is to improve the delivery of care, improve collection and availability of clinical information, increase patient safety, and improve patient outcomes.

Key Points:

JUNO BEACH, Fla., Nov. 16, 2023 /PRNewswire-PRWeb/ -- Juno Health , the commercial division of DSS, Inc., has announced that the Florida Department of Children and Families ( DCF ) has chosen Juno EHR as its electronic health record (EHR) for Florida State Hospital (FSH) in Chattahoochee, FL.
"We are excited that the DCF has chosen Juno EHR to advance its behavioral health capabilities through the use of a highly flexible and configurable EHR solution," said J. Michael Fehr, Vice President, Commercial Operations at Juno Health.
By implementing Juno EHR for Behavioral Health , Florida DCF is leveraging an EHR that is a browser based, cloud native solution that can support their mission now and in the future.
"We are excited that the DCF has chosen Juno EHR to advance its behavioral health capabilities through the use of a highly flexible and configurable EHR solution," said J. Michael Fehr, Vice President, Commercial Operations at Juno Health.