Spanning the connected health ecosystem seeking to effect policy changes

CHI is a not-for-profit multistakeholder policy and legal advocacy coalition driven by a consensus of stakeholders from across the connected health ecosystem which aims to realize an environment where Americans can improve their health using digital and connected health technologies to enhance health outcomes and reduce costs equitably.

7/26/2024- Letter on the Importance of Medical Innovation

7/18/2024- Comments of the Connected Health Initiative, Input on Certain Non-Device Software Functions and Impacts to Patient Safety (Docket No. FDA-2018-N-1910)

07/03/2024-Comments of the Connected Health Initiative, Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements (89 FR 23644)

06/10/2024- CHI Comments to the Centers for Medicare & Medicaid Services and Hospital IPPS Rules for 2025

06/05/2024 – CHI Response to the Department of Justice, Department of Health and Human Services, and Federal Trade Commission’s Request for Information on Consolidation in Health Care

05/29/2024- CHI Comments to the Centers for Medicare & Medicaid Services on Medicare Program; Request for Information on Medicare Advantage Data

05/28/2024- Connected Health Initiative Comments on the Draft 2024-2030 Federal Health IT Strategic Plan

05/24/2024- State of Artificial Intelligence in Healthcare

05/13/2024- CHI Comments regarding Draft Guidance for Industry and Food and Drug Administration Staff, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act

05/03/2024- Connected Health Initiative Input on the Health Over Wealth Act

05/02/2024- Connected Health Initiative Comments on the International Medical Device Regulators Forum’s Proposed Document, ‘Medical Device Software: Considerations for Device and Risk Characterization’

03/16/2024- Connected Health Initiative Comments Re Centers for Medicare & Medicaid Services 2nd Medicare Prescription Payment Plan Guidelines

03/10/2024- FSMB Ethics and Professionalism Committee Report: Guidelines and Recommendations to Aid State Medical Boards and Physicians in Navigating the Responsible and Ethical Incorporation of AI into Clinical Practice

02/29/2024- Connected Health Initiative Comments to the Food and Drug Administration’s Request for Comments on Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes

02/14/2024- CHI Pre-Draft 2025 Physician Fee Schedule Recommendations to CMS

02/02/2024- Comments of the Connected Health Initiative regarding Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts

01/02/2024- Comments of the Connected Health Initiative to the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) on 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (HHS-ONC-2023-0007; 88 FR 23746)

9/11/2023–Connected Health Initiative Comments on the Center for Medicare and Medicaid Services’ Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental
Health Centers Conditions of Participation, Proposed Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction (CMS-1786-P; 88 FR 49552)

8/28/2023-Comments to the Centers for Medicare and Medicaid Services’ Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies;and Basic Health Program [CMS-1784-P; 88 FR 52262]

8/28/2023-Connected Health Initiative Comments on the Center for Medicare and Medicaid Services’ Medicare Program; Transitional Coverage for Emerging Technologies
(88 Fed Reg 41633; CMS-3421-NC)

8/25/2023-Multi–stakeholder Comments to the Centers for Medicare and Medicaid Services re: Medicare and Medicaid Programs: Calendar Year 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, etc. (CMS–1784–P)

7/7/2023–Comments of the Connected Health Initiative to the White House’s Office of Science and Technology Policy on Request for Information; National
Priorities for Artificial Intelligence (88 FR 34194; OSTP-TECH-2023-0007)

6/9/2023-Comments of the Connected Health Initiative to the Centers for Medicare & Medicaid Services Regarding the Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership [CMS-1785-P]

6/16/2023-Reproductive Health Care Privacy (HHS-OCR-2023-0006; 8

6/20/2023–Comments of the Connected Health Initiative to the Office of the National Coordinator for Health Information Technology on Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HHS-ONC-2023-0007; 88 FR 23746)

5/1/2023–Connected Health Initiative Comments on the Food and Drug Administration’s Discussion Paper on Artificial Intelligence  in Drug Manufacturing [Docket No. FDA-2023-N-0487; 88 FR 12943]

2/14/2023 – CHI Comments on HHS SAMHSA “Medications for the Treatment of Opioid Use Disorder”

11/28/2022–CHI ask to extend the safe harbor for telehealth coverage by HDHPs

11/14/2022–Comments of the Connected Health Initiative, Request for Information on the Cyber Incident Reporting for Critical Infrastructure Act of 2022, 87 FR 55833

09/13/2022 – Connected Health Initiative Comments on the Center for Medicare and Medicaid Services’ Proposed CY2023 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CMS-1772-P; 87 FR 44502)

08/31/2022 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services on Medicare and Medicaid Programs; Conditions of Participation (CoPs) for Rural Emergency Hospitals (REH) and Critical Access Hospital CoP Updates (87 FR 40350)

08/29/2022 – Comments to the Centers for Medicare and Medicaid Services’ Medicare Program; Request for Information on Medicare [CMS-4203-NC; 87 FR 46918]

08/22/2022 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services on Medicare Program; End-Stage Renal Disease Prospective Payment System

8/12/2022 – Comments on the Medicare Physician Fee Schedule (PFS) Proposed Rule for calendar year (CY) 2023

06/17/2022 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services Regarding the Medicare Program (IPPS Rule)

06/06/2022 – Considerations for Implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act, as Amended

05/25/2022 – Initiative’s Comments in Response to AHRQ’s Request for Information on Proposed Patient Centered Outcomes Research Trust Fund Strategic Framework

05/24/2022 – CHI urges the White House’s National Artificial Intelligence Advisory Committee to create a standing health care subcommittee

05/17/2022 – CHI urges the Federal Communications Commission to affirm that states can utilize short codetexting to reach and provide resources to Medicaid-eligible patient

4/30/2022 – Comments of the Connected Health Initiative (CHI) Regarding the Office of the National Coordinator for Health Information Technology’s Draft v3 U.S. Core Data for Interoperability

4/29/2022 – Comments of the Connected Health Initiative to the National Institute of Standards and Technology on its Artificial Intelligence Risk Management Framework Concept Paper

3/31/2022 – Request for Information (RFI) on Strengthening Community Health Through Technology

3/25/2022 – Request for Information: Electronic Prior Authorization Standards, Implementation Specifications, and Certification Criteria

3/23/2022 – Draft Guidance for Industry and FDA, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

3/22/2022 – Draft Guidance for Industry and FDA, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

3/09/2022 – Letter to New FDA Commissioner Robert Califf

2/28/2022 – Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy

2/15/2022 – Solicitation of New Safe Harbors and Special Fraud Alerts

2/09/2022 – Chi Letter To Cms Regard Approach To Artificial Intelligence

2/02/2022 – Draft Guidance for Industry and FDA, Premarket Software Functions Guidance

2/01/2022 – Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities

4/07/2021 – CHI Letter of Support for Tech to Save Moms Act

4/20/2020 – CHI pre-rulemaking input to CMS on its draft CY2021 Physician Fee Schedule

4/6/2020 – CHI Comments to CMS regarding Medicare advantage, Part D, and PACE

4/5/2020 – CHI comments to ONC on its proposed 2020-2025 Federal Health IT Strategy

1/10/2020 – Comments of the Connected Health Initiative on Request for Public Comments on a DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance (84 FR 60398)

12/31/2019 – Medicare Program; Request for Information Regarding the Physician Self-Referral Law (CMS-1720-P) 

12/31/2019 – Multi-stakeholder Comments to the Food & Drug Administration on Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (OIG-0936-AA10-P)

12/31/2019 – Comments of the Connected Health Initiative regarding Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (OIG-0936-AA10-P)

12/26/2019 – Comments of the Connected Health Initiative Regarding the Food and Drug Administration’s Draft Guidance for Industry and Food and Drug Administration Staff on Clinical and Patient Decision Support Software (Docket No. FDA-2017-D-6569)

10/11/2019 – Request for Information for the Development of a CMS Action Plan to Prevent Opioid Addiction and Enhance Access to Medication-Assisted Treatment (MAT)

9/16/2019 – Multi-stakeholder Comments to the Centers for Medicare and Medicaid Services on Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures (84 FR 34478)

9/16/2019 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services on Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures (84 FR 34478)

9/16/2019 – Multi-stakeholder Comments to the Centers for Medicare and Medicaid Services on Medicare Program: CY2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc. (CMS-1715-P)

9/16/2019 – Medicare Program: CY2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc. (CMS-1715-P) 

9/9/2019 – Multi-stakeholder Comments to the Centers for Medicare and Medicaid Services on Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements (84 FR 34598)

9/9/2019 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services on Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements (84 FR 34598)

8/27/2019 – Comments of ACT | The App Association’s Connected Health Initiative (Transparency Reg. # 7202951387754) to The European Commission’s Directorate-General for Research and Innovation on its Roadmap Consultation, “European Partnership for Innovative Health” 

6/17/2019 – Comments of the Connected Health Initiative regarding the Office of the National Coordinator for Health Information Technology’s Draft Trusted Exchange Framework for the Interoperable Exchange of Electronic Health Information 

6/11/2019 – Reconsideration of National Coverage Determination for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R)

6/4/2019 – 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Comment Summary (Docket No. CMS-9115-P)

6/4/2019 – 21st Century Cures Act: Interoperability, Information blocking, and the onc health it certification program comments (Docket No. cms-9115-p)

6/4/2019 – Comments of the Connected Health Initiative on the Food and Drug Administration’s Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning Based Software as a Medical Device: Discussion Paper and Request for Feedback (FDA-2019-N-1185)

6/4/2019 – Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-Facilitated Exchanges and Health Care Providers (Docket No. CMS-9115-P) 

5/9/2019 – Proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring (Administrative File: CAG-00067R2) 

5/2/2019 – Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments (Docket No. FDA-2018-N-3017)

4/1/2019 – Response to Request for Information (RFI) Re: A Revised Telehealth and Digital Health Package 

3/18/2019 – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (Docket No. FDA-2018-D-3443)

3/15/2019 – Comments of the Connected Health Initiative to the National Science Foundation’s Networking and Information Technology Research and Development National Coordination Office Regarding New Approaches to Solve the Interoperability Issues between Medical Devices, Data, and Platforms

3/8/2019 – Comments of the Connected Health Initiative on Developing a Software Pre-Certification Program: A Working Model (v1.0 – January 2019) (Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program, Docket No. FDA-2017-N-4301)

3/1/2019 – Improvement Activities Performance Category Call for Activities Submission Form: Improving Patient Safety Through Cybersecurity Hygiene Education

3/1/2019 – Improvement Activities Performance Category Call for Activities Submission Form: Discuss Patient-Facing Software Applications with Beneficiaries

3/1/2019 – Improvement Activities Performance Category Call for Activities Submission Form: Cybersecurity Risk Management Practices

3/1/2019 – Improvement Activities Performance Category Call for Activities Submission Form: Clinician Engagement with Technology Developer Community

2/12/2019 – Request for Information on Modifying HIPAA Rules to Improve Coordinated Care
(Docket No.: HHS-OCR-0945-AA00)

1/28/2019 – Comments of the Connected Health Initiative on the Draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs

12/31/2018 – Multi-stakeholder Comments to the Centers for Medicare and Medicaid Services on Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service, and Medicaid Managed Care Programs for Years 2020 and 2021 (83 FR 54982)

10/26/2018 – Comments of the Connected Health Initiative regarding Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP (83 FR 43607)

10/17/18 – Request for Information Regarding the 21st Century Cures Act Electronic Health Record Reporting Program (83 FR 42913)

9/10/2018 – CHI Comments to the Federal Communications Commission In the Matter of Promoting Telehealth for Low-Income Consumers

9/10/2018 – Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program (CMS-1693-P)

8/31/2018 – Comments of the Connected Health Initiative to the Centers for Medicare and Medicaid Services on Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations (83 FR 32340)

8/24/2018 – Medicare Program; Request for Information Regarding the Physician Self-Referral Law (CMS-1720-NC)

7/6/2018 – RFI Regarding Healthcare Sector Innovation and Investment Workgroup (HHS-OS-2018-0011-0001)

6/29/2018 – Medicare Promoting Interoperability Program Call for Measures Submission Form

6/25/2018 – Comments of the Connected Health Initiative Regarding the Centers for Medicare and Medicaid Services Regarding Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims (CMS-2018-0046)

08/17/2018 – CHI Response to July 2018 RFI from the Health Innovation Caucus

06/11/2018 – Comments To The Centers For Medicare And Medicaid Services On The Benefits Of Remote Monitoring Innovations In The Medicare Program

05/31/2018 – Comments To The House Committee On Energy And Commerce On The Cybersecurity Risks Presented By Legacy Technologies

05/10/2018 – Letter to the White House on Efforts to Support the Use of Connected Health Technology

04/19/2018 – Letter to U.S. Drug Enforcement Administration on Reducing Regulatory Barriers for Electronic Prescribing of Controlled Substances

02/20/2018 – Comments to the hhs office of the national coordinator for health it on the draft USCDI

02/20/2018 – comments to the HHS Office of the National Coordinator for Health it on the draft tefca

02/06/2018 – Comments To The Food And Drug Administration Regarding Its Draft Guidance For Industry And Fda Staff On Clinical And Patient Decision Support Software

02/06/2018 – comments to the food and drug administration regarding its draft guidance for industry and fda staff on changes to existing medical software policies

02/02/2018 – Comments To The Federal Communications Commission Regarding Its Efforts To Address The Growing Need For Broadband Connectivity In The Healthcare Industry

11/20/ 2017 – Comments To The Centers For Medicare And Medicaid Services On The Innovation Center

11/01/2017 – Chi Comment To Office Of Veteran Affairs On Proposed Rulemaking On Telehealth

10/26/2017 – Connected Health Initiative Letter To Hhs On The Draft Department Strategic Plan

09/11/2017 – Connected Health Initiative Multi-Association Letter To Cms Regarding 2018 Physician Fee Schedule

08/25/2017 – Chi Comments To The Office Of The National Coordinator For Health Information Technology’s Trusted Exchange Framework And Common Agreement Effort

08/21/2017 – Chi Comments To Centers For Medicare And Medicaid Services On Cy 2018 Updates To The Quality Payment Program

08/16/ 2017 – Chi Comments To European Union Directorate-General Connect On The Digital Health Roadmap Consultation

05/24/2017 – Chi Comments to the Federal Communications Commission on the Connect2Health Task Force

05/22/2017 – Comments To Hhs Office Of The National Coordinator On The Draft Patient Generated Health Data Framework White Paper

04/21/2017 – Connected Health Initiative Comments to AHRQ on Telehealth for Acute and Chronic Care

02/28/2017 – Connected Health Initiative Comments To Cms On Call For Mips Improvement Activities

01/15/2017 – Letter To European Union Directorate-General Connect On Wearable Devices

01/26/2016 – Letter to Chairman Hatch, Ranking Member Wyden, Senator Isakson and Senator Warner regarding Medicare reform

06/27/2016 – Comments to CMS Regarding Proposed Rules and Regulations on Medicare Payment

06/03/2016 – Comments regarding Medicare Access and the CHIP Reauthorization Act of 2015

04/21/2016 – Comments to the to the Food and Drug Administration (FDA) regarding the Food and Drug Administration’s Draft Guidance & Postmarket Management of Cybersecurity in Medical Devices

06/22/2015 – Letter to Senators Warner and Isakson regarding telemedicine and chronic care

06/22/2015 – Letter to Senate Finance chronic care working group from ACT | The App Association and coalition regarding telemedicine

12/28/2015 – Comments to the Food and Drug Administration regarding using technologies and innovative methods to conduct FDA-regulated clinical investigations of investigational drugs

12/15/2015 – Comments to HHS regarding the Center for Medicare and Medicaid Services’ Medicare and Medicaid Programs

11/17/2015 – Comments to the Centers for Medicare and Medicaid Services from ACT | The App Association and telehealth coalition regarding new provisions in the Medicare Access and CHIP Reauthorization Act of 2015

04/15/2015 – Comments to Office of the National Coordinator for Health Information Technology on Request for Information & Updates to the ONC Voluntary Personal Health Record Model Privacy Notice

11/02/2014 – Letter to Congress from the Secretary of Health and Human Services regarding updating HIPAA guidance documents for the mobile world

09/18/2014 – Letter to Secretary of Health and Human Services from Congress regarding updating HIPAA guidance documents for the mobile world

09/15/2014 – Letter to Congress from ACT | The App Association and members regarding the need for updates to HIPAA guidance documents for the mobile world

11/22/2013 – Letter to the Department of Health and Human Services Health IT Policy Committee Vice Chairman from ACT and coalition regarding Stage 3 meaningful use definitions

06/25/2013
Letter to House Small Business Subcommittee on Health and Technology Chairman regarding mobile health apps