Currently, there are no regulations in place that differentiate between online advertisements and hard copy advertisements.  The FDA hopes to put guidelines in place that will “not become quickly outdated as the tools and technology evolve,” according to FDA spokeswoman Shelly L. Burgess in a NextGov report.

One issue the FDA faces with the regulation of online advertisements is that on these social media sites there is not enough space to include the full list of directions, side effects or drug interactions. The FDA hopes to put guidelines into place that will require promotional messages to be accurate and not deceptive.

A possible way to get around this shortfall of the Internet is to require a graphic that would indicate that the information is accurate. In a way, it would be a “seal of approval.” However, the FDA has not yet confirmed that this concept will be carried out.

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The initiative includes helping communities improve nutrition, as well as motivate more physical activity and decrease smoking. According to a HHS press release, Sebelius said, “Tobacco, obesity, poor nutrition and lack of physical activity are significant drivers of the nation’s disease rates.”

She continued on to say: “National organizations have the knowledge and experience to help communities tackle these hard issues. Additionally, national organization’s extensive networks will expand the reach and impact of the Communities Putting Prevention to Work initiative.”

National organizations can apply for $10 million in cooperative agreements to help communities accomplish these goals. National public or private nonprofits that are interested in applying can find information at www.grants.gov, and the deadline for the application is April 19, 2010.

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In a Notice of Proposed Rulemaking on March 2, the HHS described the two-phase certification program that will test and certify EHRs. The program involves temporary and permanent parts. The temporary program ensures that certified EHR products are available in time for purchase by eligible hospitals and doctors. The providers must buy and use those certified systems to qualify for the $17 billion in stimulus law incentive payments. Under the law, those payments will begin in October 2010.

Under the temporary certification process, the national coordinator for health IT would authorize organizations to assume testing and certification responsibilities. The temporary program ceases once the permanent program begins.

According to the Notice of Proposed Rulemaking, the national coordinator can name several organizations to conduct the certifications. Currently, the Certification Commission for Health Information Technology is the only organization that certifies EHRs.

In response to the proposed rule, CCHIT’s Executive Director Alisa Ray said the agency is confident about its prospects of becoming accredited.

“CCHIT has four years of experience testing and certifying EHRs, and promptly adapting our testing to the latest federal standards,” Ray said. “We have also been benchmarking our operations against best practices for certifying bodies, including the ISO/IEC accreditation standards, and we are well prepared. We plan to file an application with ONC as soon as they are ready to accept them.”

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Dr. David Blumenthal

Physicians, healthcare directors and chief technology officers were among those who according to ExecutiveBiz’s list of the top 10 government health IT leaders have made an impact in their field and will help form the future of health IT. Five of those who made the cut include:

National Coordinator for Health Information Technology Dr. David Blumenthal, who helped shape a national standard on how federal funds for health IT are distributed over the coming years;

Program Director for the Federal Health Architecture Vish Sankaran, who has been supporting CONNECT, an open-source application developed for secure information exchange as part of The Health and Human Services Department’s Nationwide Health Information Network;

Director of the Centers for Disease Control and Prevention Dr. Thomas Frieden, who in his previous role as New York City health commissioner helped implement the largest community of EHRs nationwide, as part of a project that focused on giving prevention-oriented information to physicians;

Administrator of the Health Resources and Services Administration Mary Wakefield, who has overseen a federal database that lists disciplinary actions against health providers;

Health and Human Services Department’s Chief Technology Officer Todd Park, who has been working on an online health map that will help citizens, employers and others better understand the healthcare systems in their local communities and how they compare to those elsewhere.

To read the complete list, click here.

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In a testimony prepared for a government hearing yesterday, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said because the reports are “purely voluntary, they may represent only the tip of the iceberg.”

In an attempt to improve the quality of medical care, reduce costs and decrease medical errors and waste, hospitals and healthcare facilities are spending up to $27 million in stimulus money to purchase electronic medical records systems that rely on digital software. However, the new systems have proven to be anything but problem free. Over the past two years, the FDA’s voluntary notification system logged 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and six deaths. In addition, the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care,” Shuren said. “However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety.”

To fix the problem, the FDA has outlined three possible approaches for tighter scrutiny. In the first scenario, FDA could require makers of the devices to register them with the government and to submit reports on safety issues and correct eventual problems.  The FDA could track this information “to help improve the design of future products.” In the second scenario, the agency could require manufacturers to report safety concerns and set minimum guidelines and standards. In the third scenario, the systems could be included in broader regulatory actions that new medical products must face before they ever reach the market.

Regulations do not guarantee safer electronic medical records and they might even limit innovation and responsiveness, said Carl Dvorak, executive vice president of Epic Systems Corporation, a company that builds systems mainly for hospitals and large medical practices. However, another vendor, Cerner Coporation, favored increased scrutiny. In the recent years, Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

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“We worked closely with users of the National Resource Directory to find out how to make the information they need easier to find,” said Noel Koch, deputy under secretary of defense for Wounded Warrior Care and Transition Policy. “The resulting re-design is easier to navigate and adds useful new features.”

The upgrade improves the ability to locate and follow the latest wounded warrior and veteran issues.  A new “bookmark and share” application helps visitors alert others to the content they’ve found most helpful through social bookmarking, Facebook, Twitter, and other social networking tools. Users are also now able to subscribe to Really Simple Syndication (RSS) or e-mail updates to receive new content, events and features based on their specific interests and needs.

“There are thousands of programs and benefits available to wounded warriors and their families, from healthcare and housing to education and employment assistance,” said Koch. “Our people must have an easy way to sift through it all to find the resources that are most helpful for their circumstances, especially while they’re dealing with what can be overwhelming challenges. That’s why we’ve partnered with the VA and Department of Labor to offer the National Resource Directory. And with the feedback mechanisms we’ve added in the re-design, we’ll be able to keep improving our service to our wounded warriors and families.”

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Health and Human Services Department Secretary, Kathleen Sebelius is aiming to improve Health IT drastically. So, How will the department go about improving Health IT initiatives? By pouring money into different grants. Last Friday, the Health and Human Services Department announced their plans to award at least $750 million in different grants to push electronic health records systems.

The Department of Labor will also aid in the push for Health IT initiatives. They will be awarding some additional grants that will increase training programs for the health IT workforce.

According to NextGov reports, Secretary Sebelius stated, “When electronic health records are designed and used correctly, there’s a huge benefit to patients and doctors. Despite this, only 20% of doctors and 10% of hospitals have even basic electronic health records. We have some distance to cover.”

The biggest challenges with the advancement of Health IT are 1) the lack of information about the electronic health records systems available and 2) the compatibility issues between different systems that make it more difficult to exchange information.

As Secretary Sebelius mentioned, there is a lot of ground to cover to advance health IT initiatives. Hopefully with the new grants, doctors and hospitals will have more trained workers and receive more support and resources that they need to adopt electronic health records.

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Federal CTO Aneesh Chopra

The federal government has launched a new partnership across government agencies and private industry to enable pregnant women and new mothers to receive free text messages that will help keep them and their babies in good health.

Texting BABY to 511411 on a moble phone (BEBE for the Spanish-language version), pregnant women can receive three free text messages every week, timed out to their due date or baby’s date of birth.  The messages focus on topics critical to maternal and child health, including birth-defect prevention, immunization, nutrition, seasonal flu, mental health, oral health, and sleep.

The program is called Text4baby, and includes private and public organizations such as the Department of Health and Human Services, the White House Office of Science and Technology Policy, and founding corporate sponsor Johnson and Johnson. Government and nonprofit health experts will provide oversight to ensure that the text messages will contain accurate health information.

U.S. Chief Technology Officer Aneesh Chopra said of the program, “Text4baby is the first free mobile health service to be taken to scale in the United States.  We know that mobile phones hold tremendous potential to inform and empower individuals,” said Chopra. “Text4baby represents an extraordinary opportunity to expand the way we use our phones, to demonstrate the potential of mobile health technology, and make a real difference for moms and babies across the country.”

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In particular, they are meeting to discuss whether or not hospitals and doctors need more guidance on exchanging electronic medical records and laboratory data. They also need to decide if they need more flexibility to achieve “meaningful use” of EHRs.

The Health and Human Services Department published the Notice of Proposed Rulemaking on January 13^th. Today the committee will consider changes in different areas of the recent proposed regulations.

The goal of today’s meeting is to deliver suggestions to clarify the current areas of uncertainty and make appropriate adjustments going forward.  It is possible that the committee will decide to drop as many as 6 meaningful use measures for next year, however, not in areas such as privacy and security.

The committee’s recommendations will be given to the Health and Human Services Department on the March 1^st, 2010.

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Of the $750 million of the grants to be awarded through HHS, $386 million will go to forty states and State Designated Entities (SDEs) to facilitate state-level Health Information Exchanges (HIEs), while $375 million will go to an additional 32 non-profit organizations to support the development of regional extension centers (RECs) to aid health professionals as they work to implement health IT.  RECs are designed to provide outreach and support services to support the HHS’ goals for health IT adoption over the next two years.

“Health information technology can make our health care system more efficient and improve the quality of care we all receive,” said Secretary of Health and Human Services Kathleen Sebelius. “These grant awards, the first of their kind, will help develop our electronic infrastructure and give doctors and other health care providers the support they need as they adopt this powerful technology.”

Over $225 million in Department of Labor grants were announced by Secretary Solis, and the grants will be used to train 15,000 people in job skills necessary to access careers in health care, health IT, and other related high-growth fields.  Through existing partnerships with local employers, grant recipients have already identified approximately 10,000 job openings for skilled workers that will likely become available over the next two years in areas like nursing, pharmacy technology and IT.  These DOL grants will fund 55 different training programs in 30 states through the DOL’s local One Stop Career Centers as well as local community colleges and other local education providers.

The HHS and DOL awards are part of an hundred-billion dollar investment in science and technology through ARRA in order to spur domestic job creation in growing industries and lay a long-term foundation for economic growth.

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