Cures Act

Prepare Now For Sharing of and Access to Electronic Health Information: Cures Act Information Blocking and Interoperability Rules Take Effect June 30, 2020 | 7/1/2020

The U.S. Department of Health and Human Services (HHS) issued companion regulations advancing the interoperability of and patient access to electronic health information under the 21st Century Cures Act that will take effect June 30, 2020, with a compliance date of November 2, 2020. Now is the time to learn what the Information Blocking Rule will require and begin the work with stakeholders to establish new practices for advancing interoperability …

HealthLX & TallulahBlue Health Partner to Help Payers Meet CMS Compliance Deadlines | PRWeb | 7/1/2020

… As a founding member of Health Level Seven International’s (HL7) Da Vinci Project, HealthLX has been working with and supporting the development of use cases and the FHIR standard itself, to comply with the Cures Act mandates. For more information, visit http://www.healthlx.com . For media inquiries, please contact: Jennifer Behnke [email protected] About TallulahBlue Health TallulahBlue Health works to move healthcare organizations beyond their traditional operating models to strengthen competitive …

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How to Develop a Cures Act Compliant Health App Solution Using OAuth2 and OpenID | 7/1/2020

How to Develop a Cures Act Compliant Health App Solution Using OAuth2 and OpenID Posted on July 1st, 2020 by Pablo Bullian On March 9, 2020, the ONC and CMS released updated rules for interoperability and patient access provisions of the bipartisan 21st Century Cures Act. The Cures Act, which was first signed into law on December 13, 2016, was designed to help accelerate medical product development. The Cures Act …

Clinical Outcome Assessments (COA) Qualification Submissions | 7/1/2020

Print The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment of the 21st Century Cures Act ), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD …

HealthLX & Timmaron Group Partner to Help Payers Meet Cures Act Mandates for Interoperability | PRWeb | 6/30/2020

HealthLX & Timmaron Group Partner to Help Payers Meet Cures Act Mandates for Interoperability Share Article Systems Integrator Partnership to Focus on Interoperability Strategy and FHIR Technology GRAFTON, Wis. HealthLX announced today that it has formed a systems integrator partnership with Timmaron Group to help healthcare payers comply with the CMS Interoperability and Patient Access final rule. By July 1, 2021, most health plans in the United States must enable member …

House Bill 1696 Printer’s Number 3630 | 6/30/2020

13001 OF THE 21ST CENTURY CURES ACT (PUBLIC LAW 114-255), AS AMENDED. “TREATMENT LIMITATION.” A LIMIT ON THE SCOPE OF A BENEFIT OR DURATION OF TREATMENT FOR A COVERED SERVICE. SECTION 2. SECTION 604-B OF THE ACT IS AMENDED TO READ: SECTION 604-B. ADOPTION OF FEDERAL ACTS. INSURERS SHALL COMPLY WITH THE FEDERAL ACTS AS CONTAINED IN SECTIONS [2701, 2702, 2705, 2707, 2721, 2753 AND 2754 OF THE …

Amniotic Products Market - Growth and key Industry Players Analysis 2020 and Forecast | 6/29/2020

… the rising incidence of burn injuries, awareness programs for wound care treatment and management, and the rise in venture capital funding and government investments. The emerging economies and the implementation of the 21st Century Cures Act are expected to provide a wide range of growth opportunities for players in the market. Market Size Estimation; Both top-down and bottom-up approaches were used to estimate and validate the total size …

HHS: Health Information Technology Advisory Committee 2020 Schedule-Revised; Meeting | 6/29/2020

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below. Start Further Info Lauren Richie, Designated …

Health groups want more time before OIG info-blocking penalties | Modern Healthcare | 6/26/2020

… six months after organizations are required to begin complying with ONC’s information-blocking provisions. “MHC in the process of updating its technological capabilities, policies and procedures to comply with the provisions of the ONC Cures Act final rule,” wrote MHC, one of a few dozen groups that submitted comments to the agency. “MHC is doing so while acting as an important partner to the healthcare community and public health authorities …

Amniotic Products Market Worth $1,095 million | Data Triangulation, Segmentation & Geographical Analysis | 6/26/2020

… the rising incidence of burn injuries, awareness programs for wound care treatment and management, and the rise in venture capital funding and government investments. The emerging economies and the implementation of the 21st Century Cures Act are expected to provide a wide range of growth opportunities for players in the market.Market Size Estimation;Both top-down and bottom-up approaches were used to estimate and validate the total size of …

CMS wants to make home health telemedicine permanent | Healthcare Dive | 6/26/2020

… fact sheet reads. The proposed rule would also impose a 5% cap on wage index decreases for one year, and finalize changes to the home health infusion therapy benefit established by the 21st Century Cures Act . Cures requires the new benefit, which allows Medicare beneficiaries to receive drugs intravenously or subcutaneously at home, to be implemented by Jan. 1, 2021. CMS estimates updating the payment rates, which is based on …

HealthTrio to Expand Interoperability API Solutions to help Health Plans meet new CMS Rules | Markets Insider | Business Insider | 6/25/2020

… Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) released final rules addressing Interoperability, Information Blocking, and the ONC Health IT Certification Program, as part of the 21st Century Cures Act . The Interoperability and Patient Access final rule (CMS-9115-F) finalizes new policies that help advance health information and data exchange, ultimately moving the entire healthcare system toward greater interoperability and allowing patients to …

CMS: Permanent telehealth changes coming to home health | Modern Healthcare | 6/25/2020

… payers and lawmakers.The agency is proposing a 5% cap on wage index cuts for 2021 and finalizing changes to home infusion therapy that must go into effect by January 1 under the 21st Century Cures Act . CMS based its proposed changes to 2021 payment rates for home infusion therapy services on the 2021 physician fee schedule.Congress created a new home infusion therapy benefit under the Cures Act to allow Medicare …

Obama and Biden, reunited again, rake in more than $11 million at virtual fundraiser - Yahoo News | 6/24/2020

Obama and Biden, reunited again, rake in more than $11 million at virtual fundraiser Melanie Mason In 2016, Vice President Joe Biden speaks before President Obama’s signature of the 21st Century Cures Act . (Charles Rex Arbogast / Associated Press) More In his first foray into this year’s presidential race, President Obama flexed some major fundraising muscle on Tuesday for Joe Biden. The duo raised more than $11 million, more than half …

ARM Yourself – A Healthcare CIO’s Introductory Guide to Apple Silicon | 6/24/2020

… and iPod Touch. Apple has grown to be one of the largest suppliers of electronic devices in healthcare. Their use by medical staff is indispensable and has enabled significant innovation. The 21 st Century CURES Act Final Rule also provides for their use by applications so patients can retrieve and use their information to improve their care via FHIR 4.0.1 APIs. The Apple Watch and HealthKit have provided significant benefit …

Application Programming Interfaces in Health IT | 6/24/2020

… OAuth 2.0, and OpenID Connect 1.0) can facilitate interoperability and serve as a catalyst for innovation and support the development of new technologies and use cases. ONC included a requirement in the 21st Century Cures Act : Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (21st Century Cures Act Final Rule) that health IT certified through the ONC Certification Program must have standardized APIs for patient and …

Stopping spiraling pharmacy costs | 6/23/2020

… Ron Wyden (DOre.) and Chuck Grassley (R-Iowa) have spent the past several months promoting their Prescription Drug Pricing Reduction Act. Meanwhile, Sen. Mike Crapo (RIdaho) is pushing his alternative, the Lower Costs, More Cures Act . Both would certainly cut drug prices — but they’d do so in vastly different ways. The Wyden-Grassley bill embraces heavyhanded government price-setting, which would cripple biotech businesses and their vendors across the country …

What the New CMS and ONC Rulings Mean for Interoperability and Your Health Organization | 6/23/2020

… landscape. The rules include directives on: Patient access to data Electronic health record (EHR) certification criteria Data exchange Information blocking This mandate is a part of a larger effort known as the 21st Century Cures Act , which places the patient at the center of a value-based healthcare system by authorizing patient access to their own health records directly from providers and payers. In Part 1, we broke down what …

Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for iBox Scoring System as a Reasonably Likely Surrogate Endpoint from the Biomarker Qualification Program | PR Newswire | 6/22/2020

… in bringing new therapies to the community and the advent of a new endpoint could really be a game changer for industry and the community we are serving.” As part of the 21st Century Cures Act , passed into law in December 2016 , public-private partnerships consisting of government entities, including the FDA, the biopharmaceutical industry, healthcare providers, academic researchers, and patient advocacy organizations are encouraged to work together to foster …

What Are the New CMS and ONC Interoperability Rules for Payers? | 6/22/2020

… issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS) to implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act). The objective is to drive interoperability and improve patient access to their own medical information so they can make better health care decisions. The CMS Interoperability Patient Access final rule ( CMS-9115 …

Could Offering EHR System Access to Community Providers Lead to Civil Monetary Penalties for Information Blocking? | 6/19/2020

Under the Office of the National Coordinator for Health IT (ONC) 21st Century Cures Act final rule, effective July 1, 2020, health care providers, in their capacities as such, are not subject to civil monetary penalties. However, health systems, hospitals and other health care providers may face civil monetary penalties if they engage in activities that cause them to be a health information technology (IT) developer of certified health IT …

Request for Information (RFI): Enhancing Rigor, Transparency, and Translatability to Improve Biomedical Research Involving Animal Models | National Institutes of Health | 6/19/2020

… this is key to the successful application of knowledge towards improving health outcomes. NIH has taken several steps in recent years, including establishment of an ACD working group in response to the 21st Century Cures Act , to improve the scientific rigor of the research it supports. In this way NIH upholds the highest standards of scientific integrity, public accountability, and social responsibility in the conduct of science. As highlighted at …

What’s Happening at the ONC – 6-19-20 | 6/19/2020

Webinars ONC’s Cures Act Final Rule Webinars Mark your calendar! ONC has a series of question and answer webinars coming up on ONC’s Cures Act Final Rule. Visit HealthIT.gov/CuresRule to learn more about the final rule. Health IT for Pediatric Care and Settings Q&A New Date: June 24 at 3 PM ET Register All webinars are recorded. Visit the Cures Rule website to see the most recent webinar …

Privacy & security perspectives: interoperability, prospects for HIPAA refresh, more - Healthcare IT News | 6/17/2020

… physician that might have been avoided had the patient data been shared. There is another significant legal pro to sharing patient data that is coming down the pike. The regulations implementing the 21st Century Cures Act , and specifically Section 4004, which prohibits what is referred to as “information blocking,” will result in potential substantial fines of up to $1 million per year being assessed against health IT developers, HINs and …

Digital Health Equity as a Necessity in the 21st Century Cures Act Era | 6/16/2020

… Robert A. Harrington, MD; Sumbul A. Desai, MD; Kenneth W. Mahaffey, MD; Mintu P. Turakhia, MD, MAS The release of final rules from the Office of the National Coordinator for Health Information Technology’s (ONC) Cures Act in March 2020 places a new focus on patients’ access to their health data. 1 The ONC rules make “health data more computable and [give] patients more control of their medical record.” 1 Hopefully …

American Hospital Association

Health groups want more time before OIG info-blocking penalties | Modern Healthcare | 6/26/2020

… months after the rule’s effective date, while the Healthcare Information and Management Systems Society advocated for six months after. The American Hospital Association asked for a six-month delay from either publication of a final … and procedures to comply with the provisions of the ONC Cures Act final rule,” wrote MHC, one of a few dozen groups that submitted comments to the agency. “MHC is doing so while acting as …

Medicare

CMS wants to make home health telemedicine permanent | Healthcare Dive | 6/26/2020

… pandemic. Home health agencies will be able to “continue to utilize telecommunications technologies in providing care to beneficiaries under the Medicare home health benefit beyond the COVID-19” emergency, such as remote patient monitoring, CMS … home health infusion therapy benefit established by the 21st Century Cures Act. Cures requires the new benefit, which allows Medicare beneficiaries to receive drugs intravenously or subcutaneously at home, to be implemented by Jan. 1 …

College of Healthcare Information Management Executives

Health groups want more time before OIG info-blocking penalties | Modern Healthcare | 6/26/2020

… month delay from either publication of a final rule or the end of the COVID-19 public health emergency. The College of Healthcare Information Management Executives recommended OIG delay enforcement of financial penalties until 2023 … and procedures to comply with the provisions of the ONC Cures Act final rule,” wrote MHC, one of a few dozen groups that submitted comments to the agency. “MHC is doing so while acting as …

HIPAA

HealthTrio to Expand Interoperability API Solutions to help Health Plans meet new CMS Rules | PRWeb | 6/25/2020

… released final rules addressing Interoperability, Information Blocking, and the ONC Health IT Certification Program, as part of the 21st Century Cures Act. The Interoperability and Patient Access final rule (CMS-9115-F) finalizes new policies … addition to exceeding requirements set forth by CMS regulations and HIPAA, this solution supports Blue Button (BB) 2.0 (Carrier Claim) guidelines as well as clinical data based on the United States Core Data for Interoperability …

Medicaid

HealthTrio to Expand Interoperability API Solutions to help Health Plans meet new CMS Rules | Markets Insider | Business Insider | 6/25/2020

Medicaid (CMS) released final rules addressing Interoperability, Information Blocking, and the ONC Health IT Certification Program, as part of the 21st Century Cures Act. The Interoperability and Patient Access final rule (CMS-9115-F) finalizes new policies that help advance health information and data exchange, ultimately moving the entire healthcare system toward greater interoperability and allowing patients to access their health information through third-party applications of their choice. CMS …

Center for Drug Evaluation and Research

Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for iBox Scoring System as a Reasonably Likely Surrogate Endpoint from the Biomarker Qualification Program | PR Newswire | 6/22/2020

… LOI) from the U.S. Food and Drug Administration (FDA) detailing the decision to accept the iBox Scoring System into the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP). In its LOI, the … community we are serving.” As part of the 21st Century Cures Act, passed into law in December 2016 , public-private partnerships consisting of government entities, including the FDA, the biopharmaceutical industry, healthcare providers, academic researchers …

Food and Drug Administration

Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for iBox Scoring System as a Reasonably Likely Surrogate Endpoint from the Biomarker Qualification Program | PR Newswire | 6/22/2020

… which Veloxis Pharmaceuticals is a member, has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the decision to accept the iBox Scoring System into … community we are serving.” As part of the 21st Century Cures Act, passed into law in December 2016 , public-private partnerships consisting of government entities, including the FDA, the biopharmaceutical industry, healthcare providers, academic researchers …

National Institutes of Health

Request for Information (RFI): Enhancing Rigor, Transparency, and Translatability to Improve Biomedical Research Involving Animal Models | National Institutes of Health | 6/19/2020

NATIONAL INSTITUTES OF HEALTH ( NIH ) Purpose This Notice is a Request for Information (RFI) inviting comments and suggestions on enhancing scientific rigor in biomedical research involving animal models. It is important to read this entire … an ACD working group in response to the 21st Century Cures Act, to improve the scientific rigor of the research it supports. In this way NIH upholds the highest standards of scientific integrity, public accountability …

NIH

Request for Information (RFI): Enhancing Rigor, Transparency, and Translatability to Improve Biomedical Research Involving Animal Models | National Institutes of Health | 6/19/2020

NATIONAL INSTITUTES OF HEALTH ( NIH ) Purpose This Notice is a Request for Information (RFI) inviting comments and suggestions on enhancing scientific rigor in biomedical research involving animal models. It is important to read this entire … an ACD working group in response to the 21st Century Cures Act, to improve the scientific rigor of the research it supports. In this way NIH upholds the highest standards of scientific integrity, public accountability …

Department of Health and Human Services

AMA Asks HHS for ‘Immediate’ Aid to Ease Clinicians’ ‘Financial Peril’ (if too long take out ‘Immediate’) | WebMD | 4/9/2020

… many of which have been crippled by the COVID-19 crisis. In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical … Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven. Medical leaders defended their request …

AMA

AMA Asks HHS for ‘Immediate’ Aid to Ease Clinicians’ ‘Financial Peril’ (if too long take out ‘Immediate’) | WebMD | 4/9/2020

AMA Asks HHS for ‘Immediate’ Aid to Ease Clinicians’ COVID-19 ‘Financial Peril’ What your doctor is reading on Medscape.com: APRIL 08, 2020 – The American Medical Association (AMA) along with scores of specialty and state … Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven. Medical leaders defended their request …

American Medical Association

AMA Asks HHS for ‘Immediate’ Aid to Ease Clinicians’ ‘Financial Peril’ (if too long take out ‘Immediate’) | 4/9/2020

… Immediate’ Aid to Ease Clinicians’ COVID-19 ‘Financial Peril’ What your doctor is reading on Medscape.com: APRIL 08, 2020 – The American Medical Association (AMA) along with scores of specialty and state medical societies are asking … Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven. Medical leaders defended their request …

Mental Health

The World’s $5 Billion Behavioral Health Care Software and Services Market, Forecast to 2027 - Key Players are Welligent, Netsmart Technologies, Epic, Core Solutions, and Cerner Corporation | PR Newswire | 4/8/2020

DUBLIN The “Behavioral/Mental Health Care Software & Services Market Size, Share & Trends Analysis Report by Component, Delivery Model, Function, End-use and Region 2020-2027” report has been added to ResearchAndMarkets.com’s offering. The global behavioral health … the Substance Abuse and Mental Health Services Administration (SAMHSA). The Cures Act provides the vendors with an opportunity of integrating, resulting in the care coordination of both parties. The act will enable interoperability between healthcare …

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 … 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 Categories (HCC …

Centers for Medicare and Medicaid Services

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 … 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 Categories (HCC …

COVID-19

US Hospitals Facing Severe Challenges From COVID-19, HHS Report Says | WebMD | 4/8/2020

US Hospitals Facing Severe Challenges From COVID-19, HHS Report Says What your doctor is reading on Medscape.com: APRIL 06, 2020 – Hospitals across the country encountered severe challenges as the first wave of the COVID … was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even …

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 … 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 greater data …

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 … 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 greater data …

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 … 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 la Cambridge …

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 … 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 la Cambridge …

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 … 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 la Cambridge …

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 … 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 charge. Tagged …

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 … 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 and over …

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 … 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; revise health …

WEDI

WEDI Provides Comments on CMS and ONC Implementing Final Provisions of the 21st Century Cures Act | PRWeb | 3/10/2020

WEDI Provides Comments on CMS and ONC Implementing Final Provisions of the 21st Century Cures Act Share Article WEDI commends the work undertaken to advance interoperability; pledges to ensure implementation enhances care coordination, safety, efficiency and value in a way that protects patient privacy. “WEDI and its members support the seamless access to health information by providers and patients to make better choices about care and treatment. At the same …

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 … 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 la Cambridge …

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 … 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 la Cambridge …

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 … 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 it is …

Audacious Inquiry

CMS final rule poses big hurdles for payers | Healthcare IT News | 3/17/2020

… by the Centers for Medicare & Medicaid Services – seek to fulfill the interoperability and information blocking provisions of the 21st Century Cures Act, laying out requirements for several segments of the healthcare industry. By Jan. 1 … or in the payer’s systems, according to an analysis by Audacious Inquiry, a health information technology and policy company. That deadline will be challenging to meet, said Danielle Lloyd, senior vice president of private market …

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

… 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 … 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

… 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 included and … 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 …

Novartis

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

… 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 included and … 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 to …

Complia Health

Complia Health Offers ContinuLink Mobile Edge, Ohio’s First Electronic Visit Verification (EVV) Third-Party Vendor. | PRWeb | 11/26/2019

Complia Health Offers ContinuLink Mobile Edge, Ohio’s First Electronic Visit Verification (EVV) Third-Party Vendor. Share Article Complia Health leads in approved third-party EVV vendors in Ohio with its mobile home care solution, ContinuLink … mandate that requires each state to be compliant with the Cures Act. The go-live date for Ohio EVV is January 1, 2020, for all Medicaid-funded home health and personal care services. Agencies not …

Accenture Healthcare

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

… 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 interoperability of … 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 …

CellTrak

CellTrak Leads the Charge Towards EVV Compliance | Globe Newswire | 10/11/2019

Over 500 million Electronically Verified Homecare Visits October 11, 2019 10:28 ET Source: CellTrak Schaumburg, IL, As one of the first innovators in mobile data collection for home health and personal care, CellTrak Technologies is on the leading edge of today’s move towards EVV compliance. Spurred by the upcoming January 1, 2020 deadline set by the 21 st Century Cures Act, agencies and care providers are relying on CellTrak for …

Aetion

Study finds real-world evidence replicates less than one-fifth of clinical trials | MedCity News | 10/11/2019

… like electronic health records, patient-reported outcome measures, insurance claims, medical devices and mobile devices. Under the 21 st Century Cures Act of 2016, the Food and Drug Administration has prioritized research into RWE and … Jeremy Rassen, president of New York-based RWE technology company Aetion, wrote in an email that rather than viewing clinical trials — especially randomized, controlled trials — and RWE as a dichotomy, he sees three different categories …

IQVIA

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

… 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 drugs or … 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 … of its work. Recall that the landmark 21 st Century Cures Act, passed by the Congress and signed into law by President Obama in December 2016, directs the FDA to evaluate RWD and consider using …

Change Healthcare

CommonWell Health Alliance Taps Change Healthcare for Clinical Interoperability Services | HIT Consultant | 6/26/2019

CommonWell Health Alliance Taps Change Healthcare for Clinical Interoperability Services //hitconsultant.net/2019/06/26/commonwell-health-alliance-change-healthcare-clinical-interoperability-services/. Captcha Submit Change Healthcare has been awarded a six-year contract by CommonWell Health Alliance … to clinical information. Along with the expected final 21st Century Cures Act regulations, including the Trusted Exchange Framework and Common Agreement (TEFCA), there is now momentum for universal clinical records interoperability. This agreement builds upon …

Teladoc

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

… 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 about the proposed interoperability … 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 ONC unveiled …

Verato

Verato asks ONC to standardize patient-matching tools | Becker’s Hospital Review | 5/6/2019

Verato asks ONC to standardize patient-matching tools Andrea Park - Print Email Verato, a provider of cloud-based patient identity matching based in McLean, Va., issued a response to the ONC’s proposed rule to implement provisions of the 21st Century Cures Act that encourage interoperability and facilitate access to and use of electronic health information. The ONC’s proposal, which was unveiled in March and remains open to public comments until …

Berkeley Research Group

Former U.S. Department Of Health And Human Services Office of Inspector General Senior Counsel Joins Berkeley Research Group | PR Newswire | 11/7/2017

Former U.S. Department Of Health And Human Services Office of Inspector General Senior Counsel Joins Berkeley Research Group News provided by 09:00 EMERYVILLE, Calif. , Nov. 7, Berkeley Research Group announced today that Kristen Schwendinger has … which was enacted as a part of the 21st Century Cures Act. “We are excited to have someone of Kristen’s caliber join BRG’s Corporate Compliance team. Her OIG and healthcare experience will strengthen our range …

BioScrip

BioScrip’s (BIOS) CEO Dan Greenleaf on Q3 2017 Results - Earnings Call Transcript | Seeking Alpha | 11/4/2017

BioScrip’s (BIOS) CEO Dan Greenleaf on Q3 2017 Results - Earnings Call Transcript Nov. 4.17 Q3 2017 Results Earnings Conference Call November 2, 2017, 9:00 am ET Executives Matt Dexter - Deputy General Counsel Dan Greenleaf - President … had to manage the negative impact of the 21st Century Cures Act, which resulted in a $24 million reduction in earnings. The company was able to offset those reimbursement reductions with savings initiatives. During the …

Allergan

Zacks Industry Outlook Highlights: Novo, Vertex Pharmaceuticals, Celgene and Ligand Pharmaceuticals - October 18, 2017 - Zacks.com | 10/18/2017

… lead to a boost in this area. Big players like Sanofi have expressed an interest in pursuing M&A deals. Allergan has also been very active on the acquisition and deal-making front. Industry bellwether … drug approval process will be much faster. The 21st Century Cures Act is a step in this direction. With the passing of this Act, expectations are that there will be more innovation in the sector …

NCI

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

… 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 Breakthrough Device … 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 …

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

… 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 Breakthrough Device … 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 …

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 … 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 make that …

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

… 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 defined in … 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

… 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 month of … 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

… 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 month of … 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 …

Mayo Clinic

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 … 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 security, and …

Study finds real-world evidence replicates less than one-fifth of clinical trials | MedCity News | 10/11/2019

Cures Act of 2016, the Food and Drug Administration has prioritized research into RWE and how it can support regulatory decision making. To conduct the study, researchers at the Mayo Clinic, Yale University, University of California San Francisco and Columbia University searched PubMed to compile a sample of 220 trials – whether or not they were randomized – published across the seven highest-impact medical journals in 2017. They found that only …

Harvard Medical School

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 …

Research Offers New Insights Into the Opioid Crisis | PR Newswire | 10/30/2017

… overdoses are by no means ‘out of the woods,’” said lead study author Scott Weiner , MD, FACEP, assistant professor at Harvard Medical School and director of the Brigham Comprehensive Opioid Response and Education Program at … example, Congress appropriated $500 Million under the 21 st Century CURES Act in 2016 to battle the opioid crisis. It’s important not to overreact, because people have legitimate pain. It took many years for us …

Department of Veterans Affairs

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

… 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 records and … 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 …

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

by Heather Landi Jun 18, 2019 12:58pm TEFCA was mandated by the 21st Century Cures Act to provide policies, procedures and technical standards necessary to exchange patient records and health information between providers, health information … 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 …

Massachusetts General Hospital

New Members Named to Serve on Health Information Technology Advisory Committee Established in 21st Century Cures Act | 11/16/2017

Contact: ONC Media Affairs202-260-6342 New Members Named to Serve on Health Information Technology Advisory Committee Established in 21st Century Cures Act Today, U.S. Department of Health and Human Services (HHS) Acting Secretary Eric D. Hargan … Oliver, Chief Medical Information Officer for Baptist Health Terrence O’Malley, Massachusetts General Hospital and Spaulding Nursing and Therapy Center North End Carolyn Petersen, patient advocate and Senior Editor for Mayo Clinic’s health information website Raj …

Former U.S. Department Of Health And Human Services Office of Inspector General Senior Counsel Joins Berkeley Research Group | PR Newswire | 11/7/2017

… Cures Act. “We are excited to have someone of Kristen’s caliber join BRG’s Corporate Compliance team. Her OIG and healthcare experience will strengthen our range of services to life sciences and other organizations, as well as their counsel.” said Ed Buthusiem , Managing Director of BRG’s Corporate Compliance and Risk Management team. Prior to her time at the OIG, Schwendinger worked at IU Health (formerly Clarian Health) and Massachusetts General Hospital

SunLink Health Systems

SunLink Health Systems, Inc. Announces Fiscal 2018 First Quarter Results | CNBC | 11/15/2017

ATLANTA–(BUSINESS WIRE)– SunLink Health Systems, Inc. (NYSE American: SSY) today announced a loss from continuing operations of $224,000 or a loss of $0.02 per fully diluted share for its first fiscal quarter ended September … Medicare reimbursement under the provisions of the 21 st Century Cures Act. SunLink had an Operating Loss 2017 of $99,000, compared to an Operating Loss 2016 of $953,000. The loss from Discontinued Operations was $53,000 …

SunLink Health Systems, Inc. Announces Fiscal 2018 First Quarter Results | Business Wire | 11/15/2017

ATLANTA- SunLink Health Systems, Inc. (NYSE American: SSY) today announced a loss from continuing operations of $224,000 or a loss of $0.02 per fully diluted share for its first fiscal quarter ended September 30, 2017 … Medicare reimbursement under the provisions of the 21 st Century Cures Act . SunLink had an Operating Loss for the quarter ended September 30, 2017 of $99,000, compared to an Operating Loss for the quarter ended …

Brigham and Women's Hospital

Research Offers New Insights Into the Opioid Crisis | PR Newswire | 10/30/2017

… MD, FACEP, assistant professor at Harvard Medical School and director of the Brigham Comprehensive Opioid Response and Education Program at Brigham and Women’s Hospital in Boston, Mass. “These patients continue to be at high-risk … example, Congress appropriated $500 Million under the 21 st Century CURES Act in 2016 to battle the opioid crisis. It’s important not to overreact, because people have legitimate pain. It took many years for us …

Research Offers New Insights Into the Opioid Crisis | PR Newswire | 10/30/2017

… MD, FACEP, assistant professor at Harvard Medical School and director of the Brigham Comprehensive Opioid Response and Education Program at Brigham and Women’s Hospital in Boston, Mass. “These patients continue to be at high-risk … example, Congress appropriated $500 Million under the 21 st Century CURES Act in 2016 to battle the opioid crisis. It’s important not to overreact, because people have legitimate pain. It took many years for us …

Regional Medical Center

Research Offers New Insights Into the Opioid Crisis | PR Newswire | 10/30/2017

Regional Medical Center in New Jersey ,” said Dr. Kivela. “Policymakers also are focused on this epidemic. For example, Congress appropriated $500 Million under the 21 st Century CURES Act in 2016 to battle the opioid crisis. It’s important not to overreact, because people have legitimate pain. It took many years for us to get to this place, and it will take time to get out.” Poll Methodology: This survey was …

Research Offers New Insights Into the Opioid Crisis | PR Newswire | 10/30/2017

Regional Medical Center in New Jersey ,” said Dr. Kivela. “Policymakers also are focused on this epidemic. For example, Congress appropriated $500 Million under the 21 st Century CURES Act in 2016 to battle the opioid crisis. It’s important not to overreact, because people have legitimate pain. It took many years for us to get to this place, and it will take time to get out.” Poll Methodology: This survey was …

Aetna

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 … 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 ONC unveiled …

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 … 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 ONC unveiled …

Joe Biden

Obama and Biden, reunited again, rake in more than $11 million at virtual fundraiser - Yahoo News | 6/24/2020

Obama and Biden, reunited again, rake in more than $11 million at virtual fundraiser Melanie Mason In 2016, Vice President Joe Biden speaks before President Obama’s signature of the 21st Century Cures Act. (Charles Rex Arbogast / Associated Press) More In his first foray into this year’s presidential race, President Obama flexed some major fundraising muscle on Tuesday for Joe Biden. The duo raised more than $11 million, more than half …

Alex Azar

AMA Asks HHS for ‘Immediate’ Aid to Ease Clinicians’ ‘Financial Peril’ (if too long take out ‘Immediate’) | WebMD | 4/9/2020

… the COVID-19 crisis. In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial … Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven. Medical leaders defended their request …

Don Rucker

MGMA Urges ONC to Slow Down Implementation of Strategic Plan | EHR Intelligence | 4/7/2020

… Plan . “We urge ONC to avoid pushing physician practices too far, too fast,” wrote MGMA in the letter addressed to Don Rucker, national coordinator for health IT. “The risks of moving too quickly include additional … can achieve the goals and vision laid out in the Cures Act.” Tagged …

Diana DeGette

DeGette calls on HHS to lift restrictions on human fetal tissue research | US House of Representatives | 4/7/2020

… 6, 2020 Press Release Move would help advance scientific research to prevent, treat and cure coronavirus DENVER, CO – U.S. Reps. Diana DeGette (D-CO), Jared Huffman (D-CA) and Jan Schakowsky (D-IL) sent a … Energy panel, also sponsored legislation last week – called the Protecting Cures Act of 2020 – to remove barriers to fetal tissue research. A PDF copy of the letter is available here . Following is the full text …

Ben Moscovitch

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

… virtual care during the COVID-19 outbreak. Any further delay in the interoperability rules timeline “impedes critical benefits to patients,” Ben Moscovitch, project director, health IT at The Pew Charitable Trusts, wrote in an April … 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 greater data …

Fred Upton

KabaFusion Announces Support for Bipartisan ‘Preserving Patient Access to Home Infusion Act’ | Business Wire | 4/1/2020

… and implements the professional services benefit in a manner consistent with what Congress intended in the bipartisan 21 st Century Cures Act . “KabaFusion applauds the introduction of the Preserving Patient Access to Home Infusion Act … by Representatives Eliot Engel (D-NY), Terri Sewell (D-AL), Fred Upton (R-MI) and Kenny Marchant (R-TX), and Senators Mark Warner (D-VA) and Tim Scott (R-SC). About KabaFusion KabaFusion was founded …

Tim Scott

KabaFusion Announces Support for Bipartisan ‘Preserving Patient Access to Home Infusion Act’ | Business Wire | 4/1/2020

… and implements the professional services benefit in a manner consistent with what Congress intended in the bipartisan 21 st Century Cures Act . “KabaFusion applauds the introduction of the Preserving Patient Access to Home Infusion Act … Marchant (R-TX), and Senators Mark Warner (D-VA) and Tim Scott (R-SC). About KabaFusion KabaFusion was founded by Dr. Sohail Masood, Pharm D., in 2010 and operates 28 home infusion specialty pharmacies strategically …

Darius Tahir

Health providers desperate for PPE take to Twitter - POLITICO | 3/27/2020

With help from Darius Tahir ( @dariustahir Quick Fix Advertisement — Clinicians desperate for PPE take to Twitter: One cardiologist is leading a grassroots movement to get care providers to speak up about how bad gear shortages … HealthIT is continuing to host public webinars about the ONC Cures Act Final Rule. Visit their dedicated website to view upcoming webinars and to watch past sessions: https://healthit.gov/curesrule/resources/webinars… CuresRuleONC HealthIT It’s …

Arthur Allen

Health providers desperate for PPE take to Twitter - POLITICO | 3/27/2020

Cures Act Final Rule. Visit their dedicated website to view upcoming webinars and to watch past sessions: https://healthit.gov/curesrule/resources/webinars… CuresRuleONC HealthIT It’s FRIDAY at Morning eHealth where the team bids a fond farewell to Arthur Allen, who can now be reached at [email protected] . Reach your author at [email protected] , and Tweet us at @dariustahir THE FDA & AGENCY IQ — The ground below our feet is shifting by …

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 … 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 it is …

Donald Rucker

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

… 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 rules have …

Bernie Sanders

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

… 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 … 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 …

Seema Verma

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

… 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 adopt standardized … they have the tools and information they need,” CMS Administrator Seema Verma said when the rules were announced. Many industry and privacy experts don’t think these measures go far enough because people often don’t read …

Jacob Reider

Hospitals gain two-year delay to implement full info-blocking provisions | Modern Healthcare | 3/11/2020

… soon as possible and industry concerns over the time it takes to develop and implement new technical capabilities, said Dr. Jacob Reider, CEO of the Alliance for Better Health and a former deputy national coordinator … past the goals outlined by Congress in the 21st Century Cures Act , which had mandated the ONC’s information-blocking regulations. The ONC in its final rule scaled back the data included to match HIPAA’s definition …

Brent Shafer

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

… 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 … it carefully to understand its impact before making judgments.” Cerner: Brent Shafer, CEO of Cerner, pledged the company’s support of the final rules, writing that giving patients free and secure access to their electronic health …

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 …

Alex Wong

HHS’ final interoperability rules standardize APIs for patient health data access through apps | MobiHealthNews | 3/9/2020

… Alex Wong/Getty Images This morning the US Department of Health and Human Services dropped its long-awaited final rules on interoperability, information blocking and patient access. While the two final documents from the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) specify a number of new requirements laid out in the 21st Century Cures Act – including those to …

Greg Walden

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

… 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 late 2016 … 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 …

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 … 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 approval pathway …

Scott Gottlieb

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

… 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 drug and … 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 …

Elizabeth Warren

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

… Answer To Democrats’ Health Care Fights? A year and a half ago, Gavin Newsom was in the same place as Elizabeth Warren and Bernie Sanders, running in a tough Democratic primary and vowing “it’s about … 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 shift from a senator, sympathetic to her home state’s health care interests …

Bill Clinton

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

… 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 shift from … 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 …

Farzad Mostashari

Q&A with Deputy National Coordinator Steven Posnack, Part 2: “We Feel Like We’re Making Progress.” | 11/13/2019

… Farzad Mostashari, Judy Murphy, Jacob Reider & others “I’m a composite of the best things each of them contributed.” The “accelerating” pace of interoperability – “We’ve entered a different phase.” Focus on the 21 st Century Cures Act Data blocking – “It’s about perspective and content.” Healthcare’s bright future: “There’s so much potential with consumer-facing technologies.” Bold Statements We always did a second look where would ask, ‘What’s the impact we’re having …

Amy Abernethy

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps | MobiHealthNews | 9/26/2019

… are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act. FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions … the agency’s oversight of CDS products,” Principal Deputy Commissioner Dr. Amy Abernethy wrote in a statement announcing the new documentation. “We heard you and worked to incorporate that important feedback.” The second is a final …

Donald Trump

When it Comes to Federal Stem Cell Regulation, Less is More | 9/17/2019

… Less is More A A A On International Rare Disease Day 2017, one month after being sworn in as President, Donald Trump gave his 2017 Joint Address to Congress. During his speech, he took particular … December 2016, for example, President Obama signed the 21st Century Cures Act into law, which contains special provisions for the “accelerated approval for advanced regenerative therapies” like SCT. Despite the clear trend toward FDA modernization …