21st Century Cures Act

Seqster Streamlines Regulatory Submissions & Health Data Sharing with FDA 21 CFR Part 11 Compliance | PR Newswire | 9/3/2020

… US-based healthcare data sources through person-centric interoperability. The company serves healthcare enterprises such as pharmaceutical companies, payers, life insurance, and providers. The platform is both FDA 21 CFR PART 11 & CMS-ONC 21st Century Cures Act Compliant. Seqster is hosted on HIPAA-compliant and HITRUST certified servers. It connects users to more than 3,000 hospitals and health systems and over 150,000 doctor offices and medical clinics nationwide. Seqster …

Ins and Outs: Medicares Proposal for Breakthrough Coverage and Other Changes | 9/2/2020

… FDA breakthrough devices will be covered for 4 years, without requiring an NCD or LCD. (An NCD could override the otherwise immediate coverage for a breakthrough device). “Breakthrough Devices” are a product of the 21st Century Cures Act in December 2016. Read about this program at FDA here . See more at [FN1]. 2. When will this happen? The sixty day comment period runs to November 2. It’s unlikely CMS would …

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IRB Approved Observational CBD Safety Study is Now Underway | PRWeb | 9/2/2020

… Exclusion criteria before they are approved and enrolled. This decentralized/virtual, observational research is powered by ValidCare StudyTM which collects Real World Evidence (RWE) from consumers across the United States in accordance with the 21st Century Cures Act . “ValidCare Study is a game changer for clinical research; especially in light of COVID-19. Now we can remotely recruit, screen, consent, monitor, and obtain intra-study feedback from participants in real …

ASCs subject to new information blocking rules, penalties — 6 things to know | Becker’s ASC Review | 9/2/2020

… practices could be subject to penalties under a new rule from the Office of the National Coordinator for Health Information Technology, according to the Ambulatory Surgery Center Association . Six things to know: 1. The 21st Century Cures Act signed into law in 2016 defined information blocking as practices “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information,” and it directed HHS to identify …

HHS announces release of $1.5 billion for local opioid response efforts | 9/1/2020

… jurisdictions to support the expansion of addiction treatment and recovery activities, with the aim of reducing unmet treatment needs and opioid overdose deaths. The two-year grant program, which was first authorized under the 21st Century Cures Act in 2016, was reauthorized in the FY 2020 appropriations bill last year following the programs initial funding cycle. As frontline providers of federal health, human services and justice programs in many states …

The perfect storm created by poorly tested pandemic vaccines: when they are not tested, manufacturers cannot be found liable for injuries | 8/30/2020

… any licensed vaccine or one authorized via an EUA. Note also that an additional Act regarding medical countermeasures and emergencies, PAHPRA was passed in 2013, so is not addressed in this 2009 article. The 21st Century Cures Act , passed in 2016 also has some relevant passages, including the fact that all vaccines recommended by CDC in pregnancy get a waiver of liability–Meryl Friday, August 7, 2009 Using New Laws …

Request for Information (RFI) on Encouraging AAALAC International-Accredited Institutions to Use Sections of the AAALAC Program Description in the OLAW Animal Welfare Assurance | National Institutes of Health | 8/28/2020

… Laboratory Animal Welfare ( OLAW ) is seeking input on encouraging AAALAC International-accredited institutions to use sections of the AAALAC International Program Description to complete applicable parts of the OLAW Animal Welfare Assurance. Background The 21st Century Cures Act , section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the …

Using Real-World Data in Single-Arm Clinical Trials: When It’s Done, Why It’s Done, How It’s Done, Upcoming Webinar Hosted by Xtalks | PRWeb | 8/27/2020

… fundamentals of synthetic control arms with a focus on oncology trials, highlighting when they are done, why they are done, and how they are done. Xtalks Life Science Webinars In the wake of the 21st Century Cures Act , FDA has shown increased amenability to use of real-world data sources to identify patients for synthetic control arms in single-arm clinical trials. TORONTO, Ontario (PRWEB) August 27, 2020 In a …

Healthcare Providers: Beware New Information Blocking Rule | Holland & Hart - Health Law Blog - JD Supra | 8/27/2020

Healthcare providers focusing on COVID-19 may have missed the final Interoperability and Information Blocking Rule that was published May 1, 2020 and takes effect November 3, 2020 . (45 C.F.R. Part 171). The Rule implements the 21st Century Cures Act and furthers the government’s efforts to enable the exchange of electronic health information (“EHI”) to facilitate better outcomes, lower costs, and greater patient access to information. In general, the Rule …

HIDI Selects Collective Medical to Upgrade Real-Time Predictive Alerts and Analytics Platform | Business Wire | 8/26/2020

… exchanges. HIDI’s program is designed in the spirit of true interoperability and in alignment with the Office of the National Coordinator for Health Information Technology and Centers for Medicare & Medicaid Services provisions of the 21st Century Cures Act . “Rapid delivery of data about patients as they move through the health care system can help improve quality and safety,” said Jonathan Heidt, M.D., board member of the Missouri College of Emergency …

Verndari, Inc. Announces Funding from U.S. Government Agency BARDA to Accelerate Development of VaxiPatch™ Dermal Patch Vaccine Technology | Business Wire | 8/26/2020

… of several companies selected by BARDA DRIVe for support in developing alternative methods for vaccine delivery technologies. BARDA DRIVe fosters public-private partnerships to accelerate the development and availability of transformative technologies under the 21st Century Cures Act . “We are excited to partner with BARDA to further develop Verndari’s VaxiPatch™ technology, which holds the promise of making vaccines more accessible and affordable while accelerating vaccine development for existing and emerging …

Verndari, Inc. Announces Funding from U.S. Government Agency BARDA to Accelerate Development of VaxiPatch™ Dermal Patch Vaccine Technology | Business & Finance | manchestertimes.com | Business Wire | 8/26/2020

… of several companies selected by BARDA DRIVe for support in developing alternative methods for vaccine delivery technologies. BARDA DRIVe fosters public-private partnerships to accelerate the development and availability of transformative technologies under the 21st Century Cures Act . “We are excited to partner with BARDA to further develop Verndari’s VaxiPatch™ technology, which holds the promise of making vaccines more accessible and affordable while accelerating vaccine development for existing and emerging …

The Difference Between HL7 and APIs: What CIOs Need to Know to Succeed with the 21st Century CURES Act Final Rule | 8/25/2020

Facebook The 21 st Century CURES Act Final Rule is a major change for healthcare data interchange. The reason being is because patients are now entitled to use Application Programming Interfaces to download their health data into their application of choice. Further reinforcing the original intent of HIPAA, this empowers patients to download their data and use it as they see fit. This legislation demonstrates an evolution of technology since …

SPH Analytics’ Launches FHIR-Based Interoperability Platform for Health Plans | PRWeb | 8/24/2020

SPH Analytics’ Launches FHIR-Based Interoperability Platform for Health Plans Share Article Leading population health company expands product portfolio to empower health plans to comply with interoperability and patient access regulations within the 21st Century Cures Act FHIRstation’s secure cloud provides a scalable and secure environment for managing PHI from healthcare providers and health plans. Payers and EHR Vendors face the classic make-or-buy decision in order to meet …

2020 SHIEC Recap: Week 1 | 8/24/2020

… Tuesday, August 18, 2020 Presenter: Don Rucker, MD, National Coordinator, Office of the National Coordinator for Health Information Technology (ONC) Overview: Dr. Rucker focuses on the value of HIEs in achieving provisions of the 21st Century Cures Act . Dr. Rucker outlined three critical facets of the 21st Century Cures Act and their value to public health planning and response. Removing barriers to interoperability is essential work. While we have made …

The Latest: Obama will say ‘our democracy’ is on the line - The Hour | 8/20/2020

President Barack Obama listens to Vice President Joe Biden make remarks before signing the 21st Century Cures Act , Tuesday, Dec. 13, 2016, in the South Court Auditorium in the Eisenhower Executive Office Building on the White House complex in Washington. less President Barack Obama listens to Vice President Joe Biden make remarks before signing the 21st Century Cures Act , Tuesday, Dec. 13, 2016, in the South Court Auditorium in the …

Citing COVID-19, Advocates Want Medicaid Caregiver Check-In Mandate Delayed | 8/20/2020

… EVV, took effect in January 2020, but many states were granted a one-year good faith extension giving them until January 2021 to come into compliance. EVV originated in a 2016 law called the 21st Century Cures Act as a way to reduce Medicaid fraud. Under the requirement, six pieces of information are supposed to be electronically verified for any personal care or home health visit — the type of service …

What the Interoperability Rule Will Mean for Payers in 2021 | HealthPayer Intelligence | 8/20/2020

… Affect Interoperability Rule Benefits? The finalized rule requires payers to provide a Patient Access application programming interface (API) which gives patients access to certain health data including personal data in accordance with the ONC 21st Century Cures Act final rule . Also, payers must offer a Provider Directory API, which clearly delineates which providers are in-network. However, CMS recognized that payers would have difficulty meeting the original deadline due to …

Antimicrobial Resistance Information from FDA | 8/20/2020

… Strategic Plan 2021-2025 (PDF, 127 KB), and announced an October 2020 NARMS Virtual Public Meeting (register by 4:00 p.m. ET, September 22, 2020 ). August 5, 2020: FDA is committed to implementing requirements in the 21st Century Cures Act to help encourage the development of safe and effective drugs for serious bacterial and fungal infections in a limited population of patients with unmet needs. Today’s final guidance on the Limited Population …

Four Ways Technology Ensures Better Healthcare Compliance | 8/20/2020

… technology ensures a more straightforward observation of laws. Key Healthcare Regulations There are many laws developed for providers to regulate individual medical information and health services. Here are the most popular of them: The 21st Century Cures Act covers the drug and device development process, modernization of health services, and digital medicine . The Food and Drug Administration Safety and Innovation Act (FDASIA) regulates the promotion of medical device innovations and …

Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure | 8/20/2020

Print What is the purpose of the Surrogate Endpoint Table? FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. This table also fulfills a 21st Century Cures Act requirement to publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product” under both …

Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health | Globe Newswire | 8/20/2020

… of the most significant in SPRI’s history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act — a law passed in December 2016 to accelerate medical discovery and innovation — to support the NIH-established Regenerative Medicine Innovation Project (RMIP). The RMIP aims to accelerate the field by supporting clinical …

New Jersey Selects HHAeXchange as State Aggregator for Electronic Visit Verification (EVV) | Benzinga | 8/19/2020

… Visit Verification (EVV) . As New Jersey’s aggregator, HHAeXchange will provide comprehensive oversight and management of the State’s EVV data in compliance with the 21 st Century Cures Act. Signed into law in 2016, the 21st Century Cures Act was designed to decrease fraud, waste, and abuse, and to help bring new innovations and medical advances faster to beneficiaries who need them. Under the Cures Act, all Medicaid personal care services …

Zyter Releases CMS Interoperability Solution for Health Insurance Payers | Globe Newswire | 8/19/2020

… of the U.S. government’s MyHealthEData initiative. On March 9, 2020, CMS released CMS-9115-F and Office of the National Coordinator for Health Information Technology (ONC) finalized technical, content and vocabulary standards in the 21st Century Cures Act Final Rule. The rules ensure clinical information is more easily available to patients through third party applications of their choice, utilizing standard based FHIR APIs, provider directories and payer-to-payer data …

The Latest: Obama will say ‘our democracy’ is on the line - Westport News | 8/19/2020

The Latest: Obama will say ‘our democracy’ is on the line Updated 5:34 pm EDT, Wednesday, August 19, 2020 President Barack Obama listens to Vice President Joe Biden make remarks before signing the 21st Century Cures Act , Tuesday, Dec. 13, 2016, in the South Court Auditorium in the Eisenhower Executive Office Building on the White House complex in Washington. less President Barack Obama listens to Vice President Joe Biden make …

HIPAA

Seqster Streamlines Regulatory Submissions & Health Data Sharing with FDA 21 CFR Part 11 Compliance | PR Newswire | 9/3/2020

21st Century Cures Act Compliant. Seqster is hosted on HIPAA-compliant and HITRUST certified servers. It connects users to more than 3,000 hospitals and health systems and over 150,000 doctor offices and medical clinics nationwide. Seqster is privately held and headquartered in San Diego . If you are interested in partnering with Seqster, please contact: [email protected] Learn more about our technology at seqster.com , follow us @Seqster SOURCE Seqster Related Links …

NIH

Request for Information (RFI) on Encouraging AAALAC International-Accredited Institutions to Use Sections of the AAALAC Program Description in the OLAW Animal Welfare Assurance | National Institutes of Health | 8/28/2020

NIH Office of Laboratory Animal Welfare ( OLAW ) is seeking input on encouraging AAALAC International-accredited institutions to use sections of the AAALAC International Program Description to complete applicable parts of the OLAW Animal Welfare Assurance. Background The 21st Century Cures Act, section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate …

Medicaid

HIDI Selects Collective Medical to Upgrade Real-Time Predictive Alerts and Analytics Platform | Business Wire | 8/26/2020

… are investing in this system to improve the value of our state’s health care system, with an emphasis on the Medicaid program,” said Herb B. Kuhn, MHA President and CEO. “Under the leadership of Gov … Technology and Centers for Medicare & Medicaid Services provisions of the 21st Century Cures Act. “Rapid delivery of data about patients as they move through the health care system can help improve quality and safety,” said …

Population Health

SPH Analytics’ Launches FHIR-Based Interoperability Platform for Health Plans | PRWeb | 8/24/2020

SPH Analytics’ Launches FHIR-Based Interoperability Platform for Health Plans Share Article Leading population health company expands product portfolio to empower health plans to comply with interoperability and patient access regulations within the 21st Century Cures Act FHIRstation’s secure cloud provides a scalable and secure environment for managing PHI from healthcare providers and health plans. Payers and EHR Vendors face the classic make-or-buy decision in order to meet …

Regenerative Medicine

Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health | Globe Newswire | 8/20/2020

… ET Source: Steadman Philippon Research Institute VAIL, Colorado, Aug. 20, Steadman Philippon Research Institute (SPRI) has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health … disease, the United States Congress included a provision in the 21st Century Cures Act — a law passed in December 2016 to accelerate medical discovery and innovation — to support the NIH-established Regenerative Medicine Innovation Project …

National Institutes of Health

Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health | Globe Newswire | 8/20/2020

… Philippon Research Institute (SPRI) has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health (NIH). SPRI Chief Scientific Officer Johnny Huard, Ph.D. will serve as … disease, the United States Congress included a provision in the 21st Century Cures Act — a law passed in December 2016 to accelerate medical discovery and innovation — to support the NIH-established Regenerative Medicine Innovation Project …

Medicare

BlueButtonPRO™ - First Certified Solution for Cures Act Announces Integration with Microsoft Azure API for FHIR | PRWeb | 8/18/2020

… to be certified by the Office of the National Coordinator (ONC) for meeting interoperability and patient access provisions of the 21st Century Cures Act . The new combined solution will enable real time seamless integration and … HHS) announced two final rules, one by the Centers for Medicare & Medicaid Services (CMS) and the other by the ONC, implementing parts of the 21st Century Cures Act. These final rules established Application Programming Interface …

HIMSS

At ONC Tech Forum, Rucker touts value of HIEs in COVID-19 response - Healthcare IT News | 8/11/2020

While the APIs mandated by the 21st Century Cures Act will eventually enable a more “seamless experience” across the care continuum, he said, state health information exchanges have a crucial role to play in coordinating … wide-ranging conversation with Denise Hines, chief Americas officer at HIMSS (the parent company of Healthcare IT News ). Of course, a lot has changed in the world since the final rules were first published in …

TEFCA

Match without a flame: Why interoperability mandates still require operational, use-case specific platforms - MedCity News | 8/11/2020

… 21st Century Cures Act, serve an undoubtedly worthwhile purpose. Unfortunately, these rules, along with some of the other steps the government is taking to improve data sharing and interoperability (TEFCA, FHIR, open APIs, etc.), are not sufficient in and of themselves. The goal of TEFCA, for example, is to “create a single onramp for nationwide interoperability,” enabling a standardized system among health information networks to share data in a way …

Department of Health and Human Services

Health Pros: Do Not Wait to Measure ONC Interoperability Rule | EHR Intelligence | 7/13/2020

… 21st Century Cures Act. But on June 30, the Department of Health and Human Services (HHS) published the final rule in the Federal Register. The ONC final rule calls on medical providers and device developers to promote patient data access using third-party apps and APIs, while taking a hard stance on information blocking . Health IT professionals must be able to effectively measure and gauge how EHR vendors and providers …

Centers for Medicare and Medicaid Services

Health Pros: Do Not Wait to Measure ONC Interoperability Rule | EHR Intelligence | 7/13/2020

… Medicare & Medicaid Services (CMS) extended the deadline for hospitals and health IT professionals to implement the final phase of the 21st Century Cures Act. But on June 30, the Department of Health and Human Services … Healthcare Interoperability Resources (FHIR) APIs. “We recommend use of the Centers for Medicare and Medicaid Services’ (CMS’s) existing measure in the Promoting Interoperability Program, namely the percentage of unique patients provided timely access to their …

Medicare Advantage

CMS Finalizes 2021 Rate Increases for Medicare Advantage | WebMD | 4/8/2020

CMS Finalizes 2021 Rate Increases for Medicare Advantage What your doctor is reading on Medscape.com: APRIL 07, 2020 – The Centers for Medicare and Medicaid Services (CMS) announced Tuesday that it will raise per-capita payments … payments to a new risk-adjustment model required by the 21st Century Cures Act. According to the fact sheet, 75% of the risk score in 2021 will be based on the 2020 CMS-Hierarchical Condition …

Food and Drug Administration

Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration | PR Newswire | 4/6/2020

Sverige Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration - Application is Supported by Data from Pivotal Phase 3 Study for the Treatment of Deep … Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. About StrataGraft StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns …

HITAC

Pew Charitable Trusts urges HHS to move forward with health IT rules amid COVID-19 outbreak | FierceHealthcare | 4/2/2020

… the timeline , according to comments from a Centers for Medicare & Medicaid Services (CMS) representative during a Health IT Advisory Committee (HITAC) meeting on March 18. “That is something that is definitely under consideration. We’re assessing … information sharing. The rules implement interoperability provisions of the bipartisan 21st Century Cures Act. RELATED: Here are 6 ways the ONC’s new rules for opening health record access will impact the industry The rules promote …

Health IT Advisory Committee

Pew Charitable Trusts urges HHS to move forward with health IT rules amid COVID-19 outbreak | FierceHealthcare | 4/2/2020

… whether to push back the timeline , according to comments from a Centers for Medicare & Medicaid Services (CMS) representative during a Health IT Advisory Committee (HITAC) meeting on March 18. “That is something that is definitely … information sharing. The rules implement interoperability provisions of the bipartisan 21st Century Cures Act. RELATED: Here are 6 ways the ONC’s new rules for opening health record access will impact the industry The rules promote …

Health Tech

How the Coronavirus Could Push Health IT to EHR Interoperability | EHR Intelligence | 4/2/2020

Three health tech and economy experts said the coronavirus pandemic will force EHR vendors to work with one another and deploy the FHIR APIs. By April 02, 2020 - The Office of the National Coordinator for … electronic health record giants been fighting the implementation of the 21st Century Cures Act with such surprising vigor? The crux of their argument is the valid concern that poorly conceived applications could leak data a …

FHIR API

How the Coronavirus Could Push Health IT to EHR Interoperability | EHR Intelligence | 4/2/2020

… tech and economy experts said the coronavirus pandemic will force EHR vendors to work with one another and deploy the FHIR APIs. By April 02, 2020 - The Office of the National Coordinator for Health Information … electronic health record giants been fighting the implementation of the 21st Century Cures Act with such surprising vigor? The crux of their argument is the valid concern that poorly conceived applications could leak data a …

FHIR

How the Coronavirus Could Push Health IT to EHR Interoperability | EHR Intelligence | 4/2/2020

… tech and economy experts said the coronavirus pandemic will force EHR vendors to work with one another and deploy the FHIR APIs. By April 02, 2020 - The Office of the National Coordinator for Health Information … electronic health record giants been fighting the implementation of the 21st Century Cures Act with such surprising vigor? The crux of their argument is the valid concern that poorly conceived applications could leak data a …

COVID-19

Pew Charitable Trusts urges HHS to move forward with health IT rules amid COVID-19 outbreak | FierceHealthcare | 4/2/2020

… for federal policymakers to move forward with data-sharing regulations in light of increased use of virtual care during the COVID-19 outbreak. Any further delay in the interoperability rules timeline “impedes critical benefits to … information sharing. The rules implement interoperability provisions of the bipartisan 21st Century Cures Act. RELATED: Here are 6 ways the ONC’s new rules for opening health record access will impact the industry The rules promote …

OpenNotes

74% of Providers Approve of OpenNotes, Patient Data Access | Patient Engagement HIT | 3/31/2020

Patient Data Access News 74% of Providers Approve of OpenNotes, Patient Data Access The latest data from OpenNotes showed that most providers like offering patient data access, but they acknowledge it adds a little more … with patient data access requirements as a part of the 21st Century Cures Act and the ONC final interoperability rule . As part of those rules, providers are required to offer patient data access free of …

CDC

Seqster Launches COVID-19 Compass based on CDC Guidelines for Healthcare Enterprises | PR Newswire | 3/26/2020

Sverige Seqster Launches COVID-19 Compass based on CDC Guidelines for Healthcare Enterprises Interoperability platform adds real time COVID-19 symptom checker to address the urgent need to remotely identify and track infected research subjects … the latest CMS Interoperability & Patient Access final rule within the 21st Century Cures Act. Seqster is hosted on HIPAA-compliant and HITRUST certified servers. It connects users to more than 3,000 hospitals and health systems …

Sequoia Project

The Sequoia Project Announces Public Webinar: Information Blocking and Interoperability Final Rules Are Here: Now What? | Globe Newswire | 3/20/2020

Free Public Webinar to Outline Practical Implications for Key Stakeholders. March 20, 2020 09:43 ET Source: The Sequoia Project VIENNA, Va., March 20, 2020 (GLOBE NEWSWIRE) – The Sequoia Project, a non-profit dedicated to solving … the following link: https://register.gotowebinar.com/register/4217268513162686221 In 2016, the 21st Century Cures Act (Cures) became U.S. law. Cures included landmark provisions to define and promote interoperability; establish or recognize a framework for trusted exchange …

College of Healthcare Information Management Executives

HHS may delay implementation of data-sharing rules due to COVID-19 outbreak | FierceHealthcare | 3/19/2020

… the ONC’s new rules for opening health record access will impact the industry Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), agreed that the Health and Human Services department … rules implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act passed in 2016. Specifically, the regulations will allow patients to access and download their health records with third-party apps. To …

American Hospital Association

Interoperability rule exposes gaps in protecting privacy | Modern Healthcare | 3/13/2020

21st Century Cures Act in 2016, it directed HHS to force insurers and providers to adopt standardized application programming interfaces—APIs—to make it easier for doctors, hospitals, insurers and patients to share health information. HHS proposed rules, released in February 2019, meet with fierce resistance from some corners of the industry, especially on privacy . The final rules, which came out March 9, haven’t alleviated those concerns. The American Hospital …

American Medical Association

Interoperability rule exposes gaps in protecting privacy | 3/13/2020

… privacy since consumers will bear more responsibility for protecting their data under a “buyer beware” standard. When Congress passed the 21st Century Cures Act in 2016, it directed HHS to force insurers and providers to … March 9, haven’t alleviated those concerns. The American Hospital Association, American Medical Association, technology groups and privacy advocates worry that sensitive patient information could be jeopardized because patients will be able to download their health …

Cerner

How the Coronavirus Could Push Health IT to EHR Interoperability | EHR Intelligence | 4/2/2020

… which they do not have the resources. Instead, they could use EHR intercompatibility to leverage the platform ecosystem, such as Cerner recently connected Uber’s non-emergency medical transportation service.” If EHRs were interoperable, then providers … electronic health record giants been fighting the implementation of the 21st Century Cures Act with such surprising vigor? The crux of their argument is the valid concern that poorly conceived applications could leak data a …

Xtelligent Healthcare Media

How the Coronavirus Could Push Health IT to EHR Interoperability | EHR Intelligence | 4/2/2020

… for the MIT Initiative on the Digital Economy. For more coronavirus updates, visit our resource page , updated twice daily by Xtelligent Healthcare Media. On March 17, the Trump Administration announced the expansion of telehealth solutions … electronic health record giants been fighting the implementation of the 21st Century Cures Act with such surprising vigor? The crux of their argument is the valid concern that poorly conceived applications could leak data a …

Allscripts

The big trends in interoperability, innovation and the coronavirus: 7 insights from Allscripts CEO Paul Black | Becker’s Hospital Review | 3/25/2020

Paul Black, CEO of Allscripts, has spent his career in the health IT space focused on the big disruptors in healthcare and supporting better care delivery. On March 9, HHS released its final rule to … affect the healthcare delivery system in the future. On the 21st Century Cures Act. Allscripts supports the legislation and applauded the final rule. Many of the interoperability principles are already built into Allscripts systems, and …

Allscripts Healthcare Solutions

Allscripts announces full support of HHS’ commitment to patients with final interoperability rules | Business Wire | 3/12/2020

CHICAGO- Allscripts Healthcare Solutions (NASDAQ: MDRX) announced today its support for the two transformative regulations recently released by the U.S. Department of Health and Human Services’ (HHS), believing both will move patients to the center … detail the interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act). Allscripts assists patients (and our clients in serving those patients) with open platforms that enable management of all personal …

Microsoft Health

Epic, Google & 8 more health IT stakeholders react to HHS’ final interoperability rules | Becker’s Hospital Review | 3/10/2020

Epic, Cerner, Google and Microsoft are just a handful of health IT companies speaking up about HHS’ interoperability rules, which were finalized March 9. Issued in February 2019 by CMS and ONC to support the MyHealthEData and 21st Century Cures Act, the regulations will require the health IT industry to adopt standards to help patients more easily access their health data via smartphone apps. The rules will affect multiple stakeholders …

Apple Health

Epic, Google & 8 more health IT stakeholders react to HHS’ final interoperability rules | Becker’s Hospital Review | 3/10/2020

… interoperability rules, which were finalized March 9. Issued in February 2019 by CMS and ONC to support the MyHealthEData and 21st Century Cures Act, the regulations will require the health IT industry to adopt standards … HHS asking for provisions. Other tech companies , such as Cerner, Apple and Microsoft have pledged their support of the regulations, highlighting the potential to enhance patient care by making it easier to share information between …

Pfizer

Pharma Isn’t Eager To Carry Cures Act 2.0 Over Finish Line Despite Being Instrumental In Passage Of First Version | Kaiser Health News | 12/4/2019

… push the first version across the finish line isn’t nearly so eager to lend the new effort much support. The 21st Century Cures Act has been lauded since its passage for both the funding it … Canada Agreement, or USMCA. (Mauldin, Andrews and Leary, 12/2) Reuters: Pfizer, Novartis Lead $2 Billion Spending Spree On Gene Therapy Production Eleven drugmakers led by Pfizer and Novartis have set aside a combined $2 billion …

Purdue Pharma

First Edition: December 3, 2019 | Kaiser Health News | 12/3/2019

… push the first version across the finish line isn’t nearly so eager to lend the new effort much support. The 21st Century Cures Act has been lauded since its passage for both the funding it … official releases. (12/3) Stat: The History Of OxyContin, Told Through Purdue Pharma Documents STAT’s multiyear legal battle to unseal secret Purdue Pharma files in a Kentucky court has produced dozens of documents that lay bare …

GE Healthcare

Precision medicine, population health offer two sides to health improvement | Modern Healthcare | 11/30/2019

… is housed in the National Institutes of Health, launched in May of last year . It fulfills a mandate of the 21st Century Cures Act, a landmark piece of legislation signed into law during the final … the Center for Connected Medicine, a center jointly operated by GE Healthcare, Nokia and UPMC. However, based on health systems’ responses, KLAS Research and the Center for Connected Medicine categorized just 12% of their precision …

Accenture Healthcare

4 Interoperability Pillars Driving Data Access, Outcomes in 2020 | EHR Intelligence | 11/26/2019

… EHR-to-EHR are the four pillars of interoperability to examine as the calendar flips to 2020. Patient Directed The 21st Century Cures Act is designed to fuel patient access to healthcare records, while driving … and coordinate their own health care.” However, according to an Accenture survey of 76 healthcare IT executives and 19 health payers, many health organizations seem unprepared and unfamiliar with these rules, which could result in …

MEDITECH

Patient Data Access Prep Lacking Ahead of 21st Century Cures Act | Patient Engagement HIT | 10/16/2019

Patient Data Access News Patient Data Access Prep Lacking Ahead of 21st Century Cures Act Many healthcare organizations are unaware of or unprepared for the patient data access rules in the 21st Century Cures Act … to health care information should impact better outcomes.” READ MORE: MEDITECH Connects to Apple Health Records for Patient Data Access These provisions apply to any medical organization or healthcare entity that handles patient medical records …

Carequality

ONC awards The Sequoia Project coordinating responsibilities for TEFCA | FierceHealthcare | 9/4/2019

… the baseline technical and legal requirements for health information networks to share electronic health information and is part of the 21st Century Cures Act, according to ONC. The program will be funded for fiscal 2019 … The organization also partnered with health IT leaders to develop Carequality, a network-to-network trust framework to connect existing and future data-sharing networks. Last year, Carequality relaunched as an independent nonprofit. The Sequoia …

IQVIA

How Real-World Data And Real-World Evidence Are Transforming The Healthcare Industry | Health IT Outcomes | 8/21/2019

… for in a trial setting. Compliance and Regulatory Landscape The FDA recently launched its RWE Framework, as mandated by the 21st Century Cures Act passed in 2016, to help support new indications for already approved … world settings. - 2016 : Quintiles merger with IMS Holdings Inc. (now IQVIA) for $8.8 billion . One of the main rationales for the merger was to take advantage of the growing use of RWE in clinical drug …

Flatiron Health

FDA Leverages Private Sector Technology Based Tools In Its Embrace Of Real World Evidence | Forbes | 7/9/2019

… of heart with speeches, policy guidance, and now with two public-private partnerships: the recent expansion of its agreement with Flatiron Health , and a brand new collaboration with COTA Healthcare . The Flatiron collaboration initially focused … the U.S. House of Representatives voted in favor of the 21st Century Cures Act on Capitol Hill in Washington, Friday, July 10, 2015. Upton and DeGette spearheaded the act. (Photo By Al Drago/CQ Roll …

Aetion

Remember Zika? Yes, It Is Still A Problem | Kaiser Health News | 7/3/2019

… 21st Century Cures Act, to explore this idea. And late last month, New York private health care company Aetion published the findings of a study in which real-world evidence was used to try to replicate the results of a specific randomized, controlled clinical trial. (Herper, 7/3) The Washington Post: Medicare Weighs Whether To Pay For Acupuncture Seeking ways to address chronic pain without narcotics, Medicare is exploring whether to …

Change Healthcare

CommonWell enlists Change Healthcare for new interoperability work | Healthcare IT News | 6/26/2019

… exchange capabilities, such as patient ID, record locator services and document retrieval. 11:40 AM Share CommonWell Health Alliance has tapped Change Healthcare to bring information exchange technologies to members of the interoperability network. Change will … efficiency, better comply with new interoperability regulations such as the 21st Century Cures Act and TEFCA and stay competitive among the larger market forces of consumerism and value-based reimbursement. “The vision of CommonWell has …

Teladoc

Health IT stakeholders calling for ONC, CMS to ‘go back to the drawing board’ on interoperability rules | FierceHealthcare | 5/30/2019

… Teladoc. The call also included other industry organizations with serious concerns about the proposed interoperability rules, including the American Academy of Ophthalmology, the Association of Clinical Research Organizations, the Electronic Health Record (EHR) Association and the Behavioral Health Information Technology Coalition. These groups want federal healthcare policymakers to make major revisions to the proposed rules before finalizing them and also say the rules exceed the mandate of the 21st Century …

Optum

Verantos To Participate In Real-World Evidence Panel At ISPOR 2019 | Health IT Outcomes | 5/14/2019

… RWE) at ISPOR 2019 in New Orleans, La., May 18–22. Representatives from the U.S. Food and Drug Administration (FDA), Optum Health, and Syneos Health will also take part in the discussion. The panel is … evolving perspective at the FDA, in the era of the 21st Century Cures Act, to encourage the development of techniques and methodologies that enable the development of regulatory grade RWE. Together, the panelists will explore …

MiMedx

Global Regenerative Medicine Market to 2024 - Dominated by Kite Pharma, Novartis, Vericel Corp, Integra LifeSciences, Wright Medical, MiMedx, Osiris Therapeutics, Stryker Corp, and Spark Therapeutics - ResearchAndMarkets.com | Business Wire | 4/18/2019

… major players in this market are Kite Pharma (US), Novartis (Switzerland), Vericel Corporation (US), Integra LifeSciences (US), Wright Medical (US), MiMedx (US), Osiris Therapeutics (US), Stryker Corporation (US), and Spark Therapeutics (US). Product launches and … Cells in Research & Development 5.3.3 Opportunities 5.3.3.1 Implementation of the 21st Century Cures Act 5.3.3.2 Rising Demand for Organ Transplantation 6 Regenerative Medicine Market, By Type 6.1 Introduction 6.2 Cell-Based Immunotherapy & Cell Therapy Products …

McKesson

ONC: Here’s how hospitals are using EHR data beyond patient care | Healthcare IT News | 4/17/2019

… 2017. WHY IT MATTERS Hospitals are continuing to surge in their adoption and use of EHRs, partially pushed by the 21st Century Cures Act. The records enable healthcare providers to more easily record and access … comes to patient safety, most hospitals used CPSI (69 percent), McKesson (74 percent), and MedHost (66 percent). “Hospitals with any developer, except Epic and Allscripts, were least likely to use their data to develop an …

CPSI

ONC: Here’s how hospitals are using EHR data beyond patient care | Healthcare IT News | 4/17/2019

… 2017. WHY IT MATTERS Hospitals are continuing to surge in their adoption and use of EHRs, partially pushed by the 21st Century Cures Act. The records enable healthcare providers to more easily record and access … case. When it comes to patient safety, most hospitals used CPSI (69 percent), McKesson (74 percent), and MedHost (66 percent). “Hospitals with any developer, except Epic and Allscripts, were least likely to use their data …

NCI

Cancer Moonshot | National Institutes of Health | 9/9/2019

Home Cancer Moonshot In 2016, the National Cancer Institute (NCI) had initiated the Cancer Moonshot to accelerate cancer preventive, diagnostic and therapeutic innovations and medical products development; encourage collaborations and improve data sharing in the … inadequate health care coverage. The US senate had approved the 21st Century Cures Act to support Moonshot projects with a funding of $1.8 billion over seven years. NCI is hosting the Symposium on Personal Control …

Aethlon Medical Announces Fiscal 2018 Second Quarter Results | PR Newswire | 11/2/2017

… EAP devices will now be advanced under a “Breakthrough Device” designation, which FDA is establishing as a result of the 21st Century Cures Act that was signed into law on December 13, 2016 . The FDA … glycosylated viruses that are not addressed with an approved treatment.” NCI Contract – In September 2017 , the National Cancer Institute (NCI) has awarded the Company a government contract. The title of the SBIR Topic 359 Phase …

Merrill Lynch

DaVita HealthCare Partners Inc. (DVA) CEO Kent Thiry on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/8/2019

… Medicare patients. We expect this number to continue to grow roughly in proportion to the MA market growth before the 21st century Cures Act in 2021. Patient costs were down a $1.52 per treatment quarter … first question comes from Kevin Fischbeck from Bank of America Merrill Lynch. Your line is now open. KevinFischbeck Great. Thanks. Just wanted to see I guess, Kent, I think you said that the quarter came …

Allscripts Healthcare Solutions, Inc. (MDRX) CEO Paul Black on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/3/2019

… CEO Rick Poulton - President Dennis Olis - CFO Stephen Shulstein - VP of IR Conference Call Participants Michael Cherny - Bank of America Merrill Lynch Jamie Stockton - Wells Fargo Robert Jones - Goldman Sachs Charles Rhyee - Cowen & Company Richard … We were very supportive of what came out in the 21st Century Cures Act. There’s a fair number of API regulatory work around that, which we have been encouraging and plotting for a long time …

Medical Center

74% of Providers Approve of OpenNotes, Patient Data Access | Patient Engagement HIT | 3/31/2020

… patients report important benefits from reading clinical notes,” Catherine M. DesRoches, DrPH, associate professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, and lead author of the study, said in a … with patient data access requirements as a part of the 21st Century Cures Act and the ONC final interoperability rule . As part of those rules, providers are required to offer patient data access free of …

Once ‘fringe idea,’ doctors warming to patients reading encounter notes, study suggests | Healthcare Dive | 3/30/2020

21st Century Cures Act of 2016 pushed patient access to medical records into a whole new realm. Patients can not only access their records electronically and often within days of a medical visit, but their physician notes as well. Moreover, the JAMA Open study, authored by doctors and researchers from Harvard Medical School, Beth Israel Deaconess Medical Center, the University of Massachusetts, UCLA, the University of Washington and the Steele …

Harvard Medical School

74% of Providers Approve of OpenNotes, Patient Data Access | Patient Engagement HIT | 3/31/2020

… benefits from reading clinical notes,” Catherine M. DesRoches, DrPH, associate professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, and lead author of the study, said in a statement . “However, this … with patient data access requirements as a part of the 21st Century Cures Act and the ONC final interoperability rule . As part of those rules, providers are required to offer patient data access free of …

21st Century Cures Act driving FDA changes | Modern Healthcare | 9/7/2019

Print AP / Getty Images / Modern Healthcare Illustration President Barack Obama signs the 21st Century Cures Act into law on Dec. 13, 2016. The sweeping legislation had broad bipartisan support. The Food and Drug Administration last … according to Dr. Anupam Jena, a healthcare policy researcher at Harvard Medical School. “The central role of the FDA is really managing this trade-off between getting drugs to market sooner, because that benefits patients …

HCA

HHS may delay implementation of data-sharing rules due to COVID-19 outbreak | FierceHealthcare | 3/19/2020

… definitely under consideration. We’re assessing the situation and looking for feedback.” Committee member Jim Jirjis, chief health information officer at HCA Healthcare, said moving forward with the current timelines — with some requirements starting in six … rules implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act passed in 2016. Specifically, the regulations will allow patients to access and download their health records with third-party apps. To …

Health IT panel may focus on price transparency | Modern Healthcare | 10/16/2019

… Anthem Blue Cross and Blue Shield. “So it’s not going to be confusing for the consumer.” HITAC, established under the 21st Century Cures Act, provides policy recommendations to the ONC. The advisory committee’s priorities, as … Jirjis, a HITAC member and chief health information officer at HCA, adding that payers have increasingly been approaching the Nashville, Tenn.-based hospital chain about exploring ways to improve data exchange. HITAC plans to establish …

UPMC

Precision medicine, population health offer two sides to health improvement | Modern Healthcare | 11/30/2019

… is housed in the National Institutes of Health, launched in May of last year . It fulfills a mandate of the 21st Century Cures Act, a landmark piece of legislation signed into law during the final … Medicine, a center jointly operated by GE Healthcare, Nokia and UPMC. However, based on health systems’ responses, KLAS Research and the Center for Connected Medicine categorized just 12% of their precision medicine programs as mature …

Precision medicine, population health offer two sides to health improvement | Modern Healthcare | 11/30/2019

… is housed in the National Institutes of Health, launched in May of last year . It fulfills a mandate of the 21st Century Cures Act, a landmark piece of legislation signed into law during the final … Medicine, a center jointly operated by GE Healthcare, Nokia and UPMC. However, based on health systems’ responses, KLAS Research and the Center for Connected Medicine categorized just 12% of their precision medicine programs as mature …

University Medical Center

Hospitals sue HHS over $840 million in inpatient payment cuts | Modern Healthcare | 11/21/2019

… University Medical Center, asked the U.S. District Court for the District of Columbia to reverse the payment reduction for 2019. Hospitals also want HHS to boost their 2018 and 2019 payments by 0.7%—plus interest—to offset their 2017 financial losses. That’s in addition to a 0.5% payment increase for 2019 approved by Congress under the 21st Century Cures Act . “CMS has conflated (the legislation) to justify its unlawful conduct …

Nocimed Announces Publication of Using Magnetic Resonance Spectroscopy to Identify Painful Lumbar Discs in the European Spine Journal | PRWeb | 8/23/2019

… attempt to drive more precise treatment decision-making.” - Dr. Frank Phillips, MD, Professor and Director, Division of Spine Surgery, Rush University Medical Center, Chicago, IL. SAN MATEO, Calif. (PRWEB) August 23, 2019 Nocimed, the leader … in the EU, and registered with the FDA under the 21st Century Cures Act to allow for sales the US. In June 2019, Nocimed earned its first US revenues. Share article on social media or …

Mayo Clinic

HIPAA revamp talks gain momentum on the Hill - POLITICO | 11/15/2019

… targeted Google, expressed openness to the idea,” Cristiano writes. EHRs IN THE BOTTOM 9TH PERCENTILE FOR USABILITY — A study in Mayo Clinic Proceedings found a strong relationship between physicians’ burnout levels and poor EHR design … has been measured using this system. As ONC develops the 21st Century Cures Act-mandated EHR reporting program, usability should be a strong component, lead author Ted Melnick told POLITICO. WOMEN RULE SUMMIT 2019 - It’s …

Health IT panel may focus on price transparency | Modern Healthcare | 10/16/2019

… it has come up several times this year, according to Carolyn Petersen, co-chair of HITAC and senior editor for Mayo Clinic’s health information website. She suggested establishing a “new HITAC task force” on the … to be confusing for the consumer.” HITAC, established under the 21st Century Cures Act, provides policy recommendations to the ONC. The advisory committee’s priorities, as defined in the Cures Act, are promoting interoperability, privacy and …

Bayfront Health

IN THE CASE OF BAYFRONT HEALTH ST. PETERSBURG: Information Blocking and the Right of Access Initiative: Why do Patients Struggle to Obtain their Medical Records and What the Office of Civil Rights Intends to Do About It | 10/17/2019

… States Department of Health & Human Services – Office of Civil Rights (“OCR”), the OCR announced that it had taken action against Bayfront Health St. Petersburg (“Bayfront”), an academic medical center in St. Petersburg, Florida, to enforce … access to electronic health information (“EHI”) as required by the 21st Century Cures Act . On September 23, 2019, seven major healthcare leadership groups, including the American Health Information Management Association (“AHIMA”) and the American Medical …

INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It | LexBlog | 10/17/2019

… States Department of Health & Human Services – Office of Civil Rights (“OCR”), the OCR announced that it had taken action against Bayfront Health St. Petersburg (“Bayfront”), an academic medical center in St. Petersburg, Florida, to enforce … access to electronic health information (“EHI”) as required by the 21st Century Cures Act . On September 23, 2019, seven major healthcare leadership groups, including the American Health Information Management Association (“AHIMA”) and the American Medical …

Department of Veterans Affairs

Remember Zika? Yes, It Is Still A Problem | Kaiser Health News | 7/3/2019

… more expensive and time-consuming studies currently considered the gold standard. The Food and Drug Administration is required, under the 21st Century Cures Act, to explore this idea. And late last month, New York private … feel impersonal. Mr. Ringler is at the forefront of the Department of Veterans Affairs’ effort to use what is known as “narrative medicine”—in which a patient is asked to tell their life story, and …

4 problems industry groups have with the ONC’s Trusted Exchange Framework | FierceHealthcare | 6/19/2019

… January 2018 as a framework designed to improve data sharing between health information networks. The framework (PDF), mandated by the 21st Century Cures Act, provides the policies, procedures and technical standards necessary to exchange patient … in TEFCA to ONC’s information blocking rule or enabling the Department of Veterans Affairs (VA) to require participation for providers who want to provide care to veterans under the Mission Act. RELATED: ONC unveils long …

Aetna

Former congressman will lobby for TikTok - POLITICO | 11/19/2019

… moved further from supporting her home-state companies, and there’s no better evidence of that than her vote against the 21st Century Cures Act.’” DEMOCRATS QUESTION STUDY COMMISSIONED BY PRIVATE EQUITY LOBBY: “Sen. Elizabeth Warren … of private equity takeovers.” IF YOU MISSED IT ON MONDAY: Aetna is rejoining America’s Health Insurance Plans , POLITICO ’s Dan Diamond reports. Aetna was one of several big-name insurers to depart the trade group …

Health IT stakeholders calling for ONC, CMS to ‘go back to the drawing board’ on interoperability rules | FierceHealthcare | 5/30/2019

… on a call with reporters Thursday organized by the Health Innovation Alliance, which represents 75 healthcare and technology organizations including Aetna, IBM, Athenahealth and Teladoc. The call also included other industry organizations with serious concerns … and also say the rules exceed the mandate of the 21st Century Cures Act and go far beyond the intent of Congress. RELATED: AMIA says ONC rule doesn’t go far enough on patients’ data access …

Seema Verma

What the Interoperability Rule Will Mean for Payers in 2021 | HealthPayer Intelligence | 8/20/2020

… application programming interface (API) which gives patients access to certain health data including personal data in accordance with the ONC 21st Century Cures Act final rule . Also, payers must offer a Provider Directory API, which … the healthcare industry as it fights COVID-19,” CMS Administrator Seema Verma said at the time. The implications for payers in 2021 The CMS final rule applies to most public payer entities across Medicare, Medicaid …

Alex Azar

Pew Charitable Trusts urges HHS to move forward with health IT rules amid COVID-19 outbreak | FierceHealthcare | 4/2/2020

… at The Pew Charitable Trusts, wrote in an April 2 letter to Department of Health and Human Services (HHS) Secretary Alex Azar. “The new regulations to promote data sharing play an essential role in ensuring … information sharing. The rules implement interoperability provisions of the bipartisan 21st Century Cures Act. RELATED: Here are 6 ways the ONC’s new rules for opening health record access will impact the industry The rules promote …

Paul Black

The big trends in interoperability, innovation and the coronavirus: 7 insights from Allscripts CEO Paul Black | Becker’s Hospital Review | 3/25/2020

Paul Black, CEO of Allscripts, has spent his career in the health IT space focused on the big disruptors in healthcare and supporting better care delivery. On March 9, HHS released its final rule to … affect the healthcare delivery system in the future. On the 21st Century Cures Act. Allscripts supports the legislation and applauded the final rule. Many of the interoperability principles are already built into Allscripts systems, and …

Donald Rucker

ONC’s Rucker: Interoperability puts American consumers in control of healthcare | FierceHealthcare | 3/18/2020

… 21st Century Cures Act. The ONC’s information blocking rule (PDF) requires that electronic health data be made available to patients at no cost and defines exceptions to data blocking. Speaking about recently released interoperability regulations, Donald Rucker, M.D., the national coordinator for health IT, said the rules will “materially change the state of patient care and patient control over their health data” and will create a healthcare app economy. The …

Joe Biden

Talk of the County: If Biden wins, Obama will ‘pull the strings on the marionette’ - Chicago Tribune | 3/16/2020

Talk of the County: If Biden wins, Obama will ‘pull the strings on the marionette’ Lake County News-Sun Mar 16, 2020 12:47 PM FILE - In this Dec. 13, 2016 file photo, President Barack Obama listens as Vice President Joe Biden speaks before signing the 21st Century Cures Act, Tuesday, Dec. 13, 2016, in the South Court Auditorium in the Eisenhower Executive Office Building on the White House complex in …

Bernie Sanders

Talk of the County: If Biden wins, Obama will ‘pull the strings on the marionette’ - Chicago Tribune | 3/16/2020

… In this Dec. 13, 2016 file photo, President Barack Obama listens as Vice President Joe Biden speaks before signing the 21st Century Cures Act, Tuesday, Dec. 13, 2016, in the South Court Auditorium in the … AP) Manchurian candidate Democrats are now trying to unify between Bernie Sanders and Joe Biden as to who’s going to be the leader of the Democratic Party. They’re talking about unity. First you’ve got Bernie …

Don Rucker

What You Need to Know About Information Blocking - HealthLeaders Media | 3/13/2020

21st Century Cures Act , ONC was responsible for defining what doesn’t constitute data blocking. Information blocking provisions are geared to certified electronic health record (EHR) developers, health information exchanges and networks—which were combined into a single definition—and providers, said ONC National Coordinator Don Rucker, MD, during a media briefing with reporters earlier this week. While the rules will not be enforced for the first six months, those who …

Jackie Drees

HHS finalizes interoperability rules: 7 things to know | Becker’s Hospital Review | 3/9/2020

HHS finalizes interoperability rules: 7 things to know Jackie Drees - Print Email HHS on March 9 finalized two interoperability rules that will give patients secure and free access to their health data. The two rules, issued by ONC and CMS, support the MyHealthEData Initiative and 21st Century Cures Act. Click here to view a timeline of Becker’s Hospital Review ‘s coverage of the rules since they were first proposed in …

Diana DeGette

Pharma’s not nearly as excited for Cures 2.0 — yet | STAT | 12/3/2019

Diana DeGette (D-Colo.) Zach Gibson/AP W ASHINGTON — The bipartisan duo behind a 2016 law that poured billions into medical research want to repeat their success. But so far, the pharmaceutical industry that helped push the first version across the finish line isn’t nearly so eager to lend the new effort much support. The 21st Century Cures Act has been lauded since its passage for both the funding it …

Fred Upton

Pharma’s not nearly as excited for Cures 2.0 — yet | STAT | 12/3/2019

21st Century Cures Act has been lauded since its passage for both the funding it included and its revamp of the regulatory landscape for medical breakthroughs. The bill’s architects, Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have spent the last four months pushing a sequel, dubbed Cures 2.0, on a mini speaking tour around Washington. Unlock this article by subscribing to STAT Plus and enjoy your first …

Elizabeth Warren

First Edition: December 3, 2019 | Kaiser Health News | 12/3/2019

… Less Disruptive Health Care Option Could Be Plenty Disruptive The single-payer health plans proposed by Senators Bernie Sanders and Elizabeth Warren are often assailed as being too disruptive. A government plan for everyone, the … so eager to lend the new effort much support. The 21st Century Cures Act has been lauded since its passage for both the funding it included and its revamp of the regulatory landscape for medical …

Donald Trump

First Edition: December 3, 2019 | Kaiser Health News | 12/3/2019

… of Iowa. Biden, among the leaders in the 16-member Democratic field for the right to take on Republican President Donald Trump in next year’s election, is proposing expanding the Affordable Care Act. (12/3) The … so eager to lend the new effort much support. The 21st Century Cures Act has been lauded since its passage for both the funding it included and its revamp of the regulatory landscape for medical …

Darius Tahir

Cures 2.0 campaign commences - Politico | 11/25/2019

and Darius Tahir ( @dariustahir ) PROGRAMMING NOTE: POLITICO’s Morning eHealth will not publish on Friday, Nov. 29. We’ll be back on our normal schedule on Monday, Dec. 2. Story Continued Below — Cures 2.0 campaign commences: Reps … input on a potential new bill building on the expansive 21st Century Cures Act, which touched health data, precision medicine and NIH funding. Last week they released their broad vision for a health law improving …

Greg Walden

No safety switch: How lax oversight of electronic health records puts patients at risk | FierceHealthcare | 11/22/2019

… consumer advocacy group Public Citizen accused FDA officials of collaborating with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in … Joseph Pitts of Pennsylvania and communications and technology subcommittee Chairman Greg Walden of Oregon argued that ONC had failed to satisfy their concerns over what Blackburn termed regulatory “mission creep.” At a House hearing in …

Karen DeSalvo

No safety switch: How lax oversight of electronic health records puts patients at risk | FierceHealthcare | 11/22/2019

… consumer advocacy group Public Citizen accused FDA officials of collaborating with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in … worry about “a misguided system of regulation.” Former ONC director Karen DeSalvo said she was five months on the job and felt completely blindsided by the line of questioning—despite the National Academy of Sciences …

David Blumenthal

No safety switch: How lax oversight of electronic health records puts patients at risk | FierceHealthcare | 11/22/2019

… consumer advocacy group Public Citizen accused FDA officials of collaborating with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in … 2010 testimony did not appear to carry much weight with David Blumenthal, a Harvard physician chosen as the Obama administration’s point man for the digital medical record rollout. Blumenthal declined to comment. Many in Blumenthal’s …

Janet Woodcock

Remarks by Anna Abram to the Biocom Celebration of Life Dinner - 11/21/2019 | 11/22/2019

… 1 products - therapies that are individualized down to a single person, an issue that two of our center directors, Dr. Janet Woodcock and Dr. Peter Marks, addressed in a recent New England Journal of Medicine … doesn’t account for the long list of enhancements in the 21st Century Cures Act. Cures created a priority review pathway for breakthrough medical devices, the regenerative medicine advanced therapy designation program, and a limited population …

Marsha Blackburn

No safety switch: How lax oversight of electronic health records puts patients at risk | FierceHealthcare | 11/22/2019

… consumer advocacy group Public Citizen accused FDA officials of collaborating with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in … and Commerce Committee Chairman Fred Upton of Michigan, Vice Chairman Marsha Blackburn of Tennessee, health subcommittee Chairman Joseph Pitts of Pennsylvania and communications and technology subcommittee Chairman Greg Walden of Oregon argued that ONC had …

Fred Schulte

No Safety Switch: How Lax Oversight Of Electronic Health Records Puts Patients At Risk | Kaiser Health News | 11/21/2019

No Safety Switch: How Lax Oversight Of Electronic Health Records Puts Patients At Risk By Fred Schulte and Erika Fry, Fortune November 21, 2019 h1 No Safety Switch: How Lax Oversight Of Electronic Health Records … with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in late 2016, all but shut the door on FDA regulation …

Scott Gottlieb

Elizabeth Warren’s health care evolution has earned her friends on the left, but foes in her home state | 11/19/2019

… November 19, 2019 Elizabeth Warren speaks to voters at Exeter High School. Jessica Rinaldi/The Boston Globe W ASHINGTON — The 21st Century Cures Act seemed tailor-made for Massachusetts. It promised Boston’s vast ecosystem of … research. Elizabeth Warren presses Pfizer to fork over information on Scott Gottlieb A year later, Senate leadership cut rank-and-file offices like Warren’s out of the process. The resulting package, Warren argued, was effectively …

Bill Clinton

First Edition: November 19, 2019 | Kaiser Health News | 11/19/2019

… Stat: Warren’s Health Care Evolution Earns Friends On The Left, Foes Back Home [Sen. Elizabeth’s] Warren’s hardline stance on [The 21st Century Cures Act] was the exclamation point on her yearslong health care transformation — a … his physical,” tweeted Joe Lockhart, a press secretary under President Bill Clinton, who was himself impeached for perjury and obstruction. “What does it mean? It means that we just won’t know what the medical issue …

Amy Klobuchar

HIPAA revamp talks gain momentum on the Hill - POLITICO | 11/15/2019

… would stop businesses from selling and sharing data gathered by fitness trackers, along with Sen. Jacky Rosen (D-Nev.). …. Sens. Amy Klobuchar (D-Minn.) and Lisa Murkowski (R-Alaska) endorsed HHS’ investigation of Google’s partnership … has been measured using this system. As ONC develops the 21st Century Cures Act-mandated EHR reporting program, usability should be a strong component, lead author Ted Melnick told POLITICO. WOMEN RULE SUMMIT 2019 - It’s …

Arthur Allen

HIPAA revamp talks gain momentum on the Hill - POLITICO | 11/15/2019

11/15/2019 10:00 AM EST With help from Arthur Allen ( @arthurallen202 ) and Darius Tahir ( @dariustahir ) Editor’s Note: This edition of Morning eHealth is published Mondays, Wednesdays and Fridays at 10 a.m. POLITICO Pro eHealth subscribers hold … has been measured using this system. As ONC develops the 21st Century Cures Act-mandated EHR reporting program, usability should be a strong component, lead author Ted Melnick told POLITICO. WOMEN RULE SUMMIT 2019 - It’s …

Lamar Alexander

Senate confirmation hearing for Dr. Hahn’s appointment as FDA Commissioner set for Nov. 20 | 11/8/2019

Senate Health Chairman Lamar Alexander, R-TN, has announced the confirmation hearing on the nomination of Dr. Stephen M. Hahn to serve as Commissioner of the Food and Drug Administration. The confirmation hearing before the … crucial perspective at a time when FDA is implementing the 21st Century Cures Act, regulating tobacco and vaping products, addressing the opioid crisis, and protecting our nation’s food supply. ” Hahn, who is currently the chief …

Farzad Mostashari

Info blocking rule coming soon? - POLITICO | 10/30/2019

… out a preventive care tool. Plus more from the business world. But first, the jump. eHealth tweet of the day: Farzad Mostashari @Farzad_MD “Powerful healthcare institutions are claiming the mantle of addressing “SDOH” by … ONC’s information blocking rule, which outlines seven exemptions to the 21st Century Cures Act’s ban on interfering with the transfer of health information, has reached OMB . CMS’ proposal, which would require the health care industry …