A Medical Device Daily

The Healthcare Information and Management Systems Society (HIMSS; Washington) last week released A Call for Action: Enabling Healthcare Reform Using Information Technology, a detailed report outlining specific priorities and recommendations for the Obama Administration and 111th Congress to harness IT's power to reform healthcare and stimulate the U.S. economy.

"President-elect Obama and U.S. Health and Human Services (HHS) Secretary-designate Daschle have clearly indicated their interest in finding ways to cost-effectively evolve our healthcare system to include 21st century technology solutions that will help improve access, decrease costs and increase quality of healthcare for millions of Americans," said Charles Christian, chair of HIMSS board and director of Information Systems and CIO, Good Samaritan Hospital (Vincennes, Indiana). "Our goal in releasing this report today is to share the expertise and recommendations of the health IT community with policymakers to help ensure health IT policy proposals achieve maximum impact for consumers and the healthcare community."

Among the specific recommendations detailed in the HIMSS report include the following priority actions:

• Invest a minimum of $25 billion in health IT to help non-governmental hospitals and physician practices adopt electronic medical records (EMRs). Additional funding should be allocated to cover EMR adoption by federal and state-owned healthcare providers, and establish health IT Action Zones. HIMSS also calls for SCHIP to be expanded to make health IT available to Medicaid and SCHIP providers of healthcare to children.

• Apply recognized standards and certified health IT products among all federally funded health programs by requiring that federal funding to assist providers and payers within these programs adopt health IT only be used for the purchase or upgrade of new health IT products that apply HITSP interoperability specifications and are CCHIT-certified.

• Expand Stark Exemptions and Anti-Kickback Safe Harbors for EMRs to cover additional healthcare software and related devices that apply HITSP interoperability specifications, are CCHIT-certified, and allow for better coordination of care and information sharing among related providers and their patients. In carrying out this recommendation, the Secretary should implement necessary measures and requirements to protect against conflict of interest and improper relationships among providers.

• Codify HITSP as the National Standards HarmonizationBody responsible for collaborating with the public and private sector to achieve a widely accepted and useful set of standards to enable the widespread interoperability among healthcare software applications. Adequate funding should be authorized and appropriated for HITSP from FY10 - FY14.

• Codify a Senior Level Health IT Leader within the Administration to oversee a national health IT strategy.

• Authorize a Federal Advisory and Coordinating Body for Health IT. Based on the experiences of the AHIC and its Successor organization, the U.S. Congress should authorize a federal advisory committee - operating under the Federal Advisory Committee Act - responsible for advising the Administration on health IT initiatives throughout the U.S. and coordinating standards harmonization through collaboration with HITSP and CCHIT.

• Conduct a White House Summit on Healthcare Reform through Information Technology to develop consensus and propose solutions to critical, national health IT issues within the context of the larger national healthcare reform effort.

"While most experts in the health IT profession recognize that the long-term benefits of moving towards a more modernized healthcare delivery system will vastly outweigh the short-term costs, we also recognize that these short-term costs are being proposed during a time of significant economic uncertainty," said H. Stephen Lieber, HIMSS president/CEO. "We are convinced that moving forward with health IT now will not only be critical to ensuring sustainable positive change for consumers, but will also provide an immediate economic stimulus in the way of new jobs across the healthcare sector."

Haemonetics receives FDA warning letter

Haemonetics (Braintree, Massachusetts) has failed to correct a variety of manufacturing issues, including taking proper steps to ensure the quality of its blood collection products, the FDA warned in a letter released this past Tuesday.

The company, which makes devices and other products to collect and process blood, must have an outside expert consultant audit its manufacturing and quality systems, the FDA also said in its letter dated Dec. 4.

FDA officials uncovered the problems while inspecting the company's Niles, Illinois, plant in June and July. Haemonetics responded to the investigators' concerns in late July, but the FDA found many of its steps were inadequate.

Among the violations were Haemonetics' failure to set up quality control procedures for suppliers and contractors. It also did not properly set up systems to verify product standards, the letter said.

Haemonetics has 15 days to respond to the FDA's warning letter. The agency can take a variety of punitive actions, including levying fines or seeking an injunction, although most similar cases are resolved without further action.