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Testimonials

In the various roles he has undertaken through the years, Val J. Halamandaris has been a singular driving force behind the policy and program initiatives resulting in the recognition of home health care as a viable alternative to institutionalization. His dedication to consumer advocacy, which enhances the quality of life and dignity of those receiving home health care, merits VNA HealthCare Group’s highest recognition and deepest respect. 

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VNA HealthCare Group

I have the highest respect for them, especially for the nurses, aides and therapists, who devote their lives to caring for people with disabilities, the infirm and dying Americans.  There are few more noble professions.

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President Barack Obama

Home health care agencies do such a wonderful job in this country helping people to be able to remain at home and allowing them to receive services

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U.S. Senator Debbie Stabenow (D-MI) Chair, Democratic Steering and Outreach Committee

Home care is a combination of compassion and efficiency.  It is less expensive than institutional care...but at the same time it is a more caring, human, intimate experience, and therefore it has a greater human element...it’s a big mistake not to try to maximize it and find ways to give people the home care option over either nursing homes, hospitals or other institutions

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Former Speaker of the U.S. House of Representatives Newt Gingrich (R-GA)

Medicaid covers long-term care, but only for low-income families.  And Medicare only pays for care that is connected to a hospital discharge....our health care system must cover these vital services...[and] we should promote home-based care, which most people prefer, instead of the institutional care that we emphasize now.

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Former U.S. Senator Majority Leader Tom Daschle (D-CD)

We need incentives to...keep people in home health care settings...It’s dramatically less expensive than long term care.

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U.S. Senator John McCain (R-AZ)

 

Home care is clearly the wave of the future. It’s clearly where patients want to be cared for. I come from an ethnic family and when a member of our family is severely ill, we would never consider taking them to get institutional care. That’s true of many families for both cultural and financial reasons. If patients have a choice of where they want to be cared for, where it’s done the right way, they choose home.

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Donna Shalala, former Secretary of Health and Human Services

A couple of years ago, I spent a little bit of time with the National Association for Home Care & Hospice and its president, Val J. Halamandaris, and I was just blown away. What impressed me so much was that they talked about what they do as opposed to just the strategies of how to deal with Washington or Sacramento or Albany or whatever the case may be. Val is a fanatic about care, and it comes through in every way known to mankind. It comes through in the speakers he invites to their events; it comes through in all the stuff he shares.

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Tom Peters, author of In Search of Excellence

Val’s home care organization brings thousands of caregivers together into a dynamic organization that provides them with valuable resources and tools to be even better in their important work. He helps them build self-esteem, which leads to self-motivation.

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Mike Vance, former Dean of Disney and author of Think Out of the Box

Val is one of the greatest advocates for seniors in America. He goes beyond the call of duty every time.

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Arthur S. Flemming, former Secretary of Health, Education, and Welfare

Val has brought the problems, the challenges, and the opportunities out in the open for everyone to look at. He is a visionary pointing the direction for us. 

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Margaret (Peg) Cushman, Professor of Nursing and former President of the Visiting Nurses Association

Although Val has chosen to stay in the background, he deserves much of the credit for what was accomplished both at the U.S. Senate Special Committee on Aging, where he was closely associated with me and at the House Select Committee on Aging, where he was Congressman Claude Pepper’s senior counsel and closest advisor. He put together more hearings on the subject of aging, wrote more reports, drafted more bills, and had more influence on the direction of events than anyone before him or since.

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Frank E. Moss, former U.S. Senator

Val’s most important contribution is pulling together all elements of home health care and being able to organize and energize the people involved in the industry.

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Frank E. Moss, former U.S. Senator

Anyone working on health care issues in Congress knows the name Val J. Halamandaris.

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Kathleen Gardner Cravedi, former Staff Director of the House Select Committee on Aging

Without your untiring support and active participation, the voices of people advocating meaningful and compassionate health care reform may not have been heard by national leaders.

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Michael Sullivan, Former Executive Director, Indiana Association for Home Care

All of us have been members of many organizations and NAHC is simply the best there is. NAHC aspires to excellence in every respect; its staff has been repeatedly honored as the best in Washington; the organization lives by the highest values and has demonstrated a passionate interest in the well-being of patients and providers.

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Elaine Stephens, Director of Home Care of Steward Home Care/Steward Health Systems and former NAHC C

Home care increasingly is one of the basic building blocks in the developing system of long-term care.  On both economic and recuperative bases, home health care will continue to grow as an essential service for individuals, for families and for the community as a whole.

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Former U.S. Senator Olympia Snowe (R-ME)

NCOA is excited to be part of this great event and honored to have such influential award winners in the field of aging.

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National Council of Aging

Health care at home…is something we need more of, not less of.  Let us make a commitment to preventive and long-term care.  Let us encourage home care as an alternative to nursing homes and give folks a little help to have their parents there.

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Former President Bill Clinton

Summary of the FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-based Framework

April 8, 2014 04:12 PM

The Food and Drug Administration (FDA), the Federal Communications Commission (FCC), and the Office of the National Coordinator for Health Information Technology (ONC) recently released a report outlining a draft strategy and recommendations for a “risk-based” regulatory framework for health IT, as required by Section 618 of the Food and Drug Administration Safety and Innovation Act FDASIA.

The draft health IT report categorizes health IT into three broad categories based on functionality. Because the Agencies used functionality as the sole criteria for grouping various types of health IT together, the draft report applies to technologies hosted on a variety of platforms, including mobile, cloud-based, and installed products. The report does not address or discuss the differences in technologies used across the care spectrum. Interested stakeholders are encouraged to submit comments to the Agencies by July 7, 2014. The Agencies also intend to hold a public meeting within the next several months to discuss the draft report.

A summary of the key recommendations is below:

Overarching Conclusions 

  • Risk and corresponding controls should focus on health IT functionality rather than the platform(s) on which the functionality resides or the product name/description.
  • No new or additional areas of FDA oversight are needed.
  • Regulatory framework should be flexible enough to accommodate innovative, continuously-evolving products and should account for the complex environment in which the products operate, as well as the multiple stakeholders that play key roles in its development, implementation and use. 

General Rules (see Appendix for examples of health IT in each category)

  • Administrative Health IT– Administrative health IT poses limited or no risk to patient safety and does not require additional oversight.
  • Health Management Health IT– Potential safety risks associated with health management health IT are generally low compared to the potential benefits. FDA does not intend to focus its oversight on health management health IT if it meets the statutory definition of a medical device.
    • The report also provides clarity on the types of clinical decision support (CDS) that FDA currently regulates, and indicates that the FDA will work with federal and private stakeholders to clarify the types of CDS that are the focus of FDA’s oversight.
  • Medical Device Health IT– FDA will focus attention and oversight on this category of health IT.

Priority Areas & Recommendations

Promote the Use of Quality Management Principles

  • The Agencies will work with health IT stakeholders to identify the essential elements of a health IT quality framework, leveraging existing quality management principles and identifying areas where quality management principles can or should be applied.

Identify, Develop and Adopt Standards and Best Practices

  • The Agencies have identified the following specific areas of focus –
  • Health IT design and development, including usability;
  • Local implementation, customization and maintenance of health IT;
  • Interoperability;
  • Quality management, including quality systems; and
  • Risk management.
  • The Agencies recommend that entities be identified to develop tests to validate interoperability, test product conformance with standards, and transparently share results of product performance to promote broader adoption of interoperable solutions.
  • The Agencies believe that the development and adoption of best practices for the local implementation, customization and maintenance of health IT should be complemented by a framework that provides independent assessments of organizational conformity to established best practices with transparency and accountability.

Leverage conformity assessment tools

  • The Agencies believe that voluntary conformity assessment tools, such as certification, product testing, and accreditation could be implemented by the private sector and applied in a risk-based manner to selected health IT.
  • The Agencies recommend that conformity assessment tools be used and applied in a risk-based manner to distinguish high quality products and organizations from those that fair to meet basic performance standards or requirements.
  • The Agencies recommend that non-governmental, independent programs to perform conformity assessments should be developed to fill current gaps.

Create an Environment of Learning and Continual Improvement

  • The Agencies agree that a voluntary, publicly accessible list of certain types of health management health IT products maintained by a non-governmental program and made available to health IT consumers could provide additional consumer transparency and promote safety. 
  • The Agencies recommend the creation of a public-private Health IT Safety Center to serve as a trusted convener of health IT stakeholders and identify the governance structures and functions need to create a health IT learning system.

Other Clarifications

Clinical Decision Support

  • The Agencies recommend that health IT stakeholders work together to develop policies for the transparent disclosure of the rules and information sources underlying individual health management CDS functionalities/products.
  • For the small subset of CDS software that are medical device health IT functionality, present higher risks, and generally have been subject to active oversight by FDA, such active oversight should be continued.

Questions for Public Comment

Quality Management Principles

  • What essential quality management principles should apply to health IT? How should they apply to different stakeholders and at different stages of the health IT product lifecycle?
  • How do we assure stakeholder accountability for adoption of quality management principles? Is there a role for a non-governmental, independent program to assess stakeholder adherence to quality management principles? Is there a role for government?

Standards and Best Practices

  • Are the identified priority areas for standards and best practices the proper areas of focus? If not, what areas should be prioritized?
  • How can the private sector help facilitate the development and adoption of applicable health IT standards and best practices? Is there a role for a non-governmental, independent program to assess product and stakeholder adherence to standards and best practices? Is there a role for government?

Conformity Assessment Tools

  • What conformity assessment tools, if any, should be incorporated into a risk-based health IT framework? How should they apply to different stakeholders and at different stages of the health IT product lifecycle? How can adoption of and adherence to conformity assessment programs be promoted?
  • Should interoperability be tested? How should tests to validate interoperability be conducted? Should interoperability standard(s) be adopted and used for conformity assessments (i.e., develop a functional standard that specifies interoperability characteristics that could be used for conformity assessment)?
  • How should the intended user (e.g., health care provider, consumer, etc.) affect the type of conformity assessment performed?
  • How should conformance assessment results be communicated to stakeholders?
  • Is there a role for a non-governmental, independent health IT conformity assessment program? Is there a role for government? Should the ONC Health IT Certification Program be leveraged to protect patient safety through the use of conformity assessment tools?

Learning Environment

  • What should be the governance structure and functions of the Health IT Safety Center, in order for it to serve as a central point for a learning environment, complement existing systems, facilitate reporting, and promote transparent sharing of adverse events, near misses, lessons learned and best practices?
  • How can comparative user experiences with health IT be captured and made available to the health IT community and other members of the public to promote learning?
  • How can the private sector help facilitate the development of a non-governmental process for listing selected health IT products? What types of products and information should be included? Should the results of conformity assessments, such as conformance with certain clinical or privacy and security standards be included?
  • In terms of risk management, what type of safety-related surveillance is appropriated for health IT products categorized as health management functionality? What continued or expanded role(s), if any, should the ONC Health IT Certification Program play in the safety-related surveillance of health IT products?
  • What role should government play in creating an environment of learning and continual improvement for health IT?

Clinical Decision Support

  • What types of CDS functionality should be subject to the health management health IT framework? Which types should be the focus of FDA oversight?
  • How should the following priority areas identified in the Health Management Health IT Framework (Section 5) be applied to CDS categorized as health management health IT functionality?
    • Quality management principles
    • Standards and best practices
    • Conformity assessments
    • Learning environment and continual improvement
  • Are there additional safeguards for CDS, such as greater transparency with respect to CDS rules and information sources that are needed to appropriately balance patient safety and the promotion of innovation?
  • Does the certification of CDS functionalities, such as those functionalities currently certified under the ONC Health IT Certification Program, sufficiently balance patient safety and the promotion of innovation?
  • How can the private sector help assure the facilitation of the development, application and adoption of high quality CDS with health management health IT functionality in lieu of a regulatory approach? What role, if any, should government play?
 

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