Surveys show significant proportions of hospitals and doctors already plan to adopt electronic health records and qualify for federal incentive payments

Four-fifths of the nation's hospitals, and 41 percent of office-based physicians, currently intend to take advantage of federal incentive payments for adoption and meaningful use of certified electronic health records (EHR) technology, according to survey data released today by the Office of the National Coordinator for Health Information Technology (ONC). The survey information was released as the registration period opened for the Medicare and Medicaid EHR Incentive Programs.

David Blumenthal, M.D., M.P.P., the National Coordinator for Health Information Technology, said the survey numbers represent a reversal of the low interest in EHR adoption in previous years. He credited leadership from the medical community and the federal government for the improved prospects for adoption and use of health information technology (health IT).

"For years we have known that electronic health records would improve care for patients and bring about greater cost effectiveness in our health sector, yet adoption rates by health care providers remained low," Dr. Blumenthal said. "In 2009, Congress and the President authorized major new federal support for EHR adoption and use, and in combination with medical professional and hospital leadership, I believe we are seeing the tide turn toward widespread and accelerating adoption and use of health IT."

The data released today comes from surveys commissioned by ONC and carried out in the course of regular annual surveillance by the American Hospital Association (AHA) and the National Center for Health Statistics (NCHS), an agency of HHS' Centers for Disease Control and Prevention (CDC).

The AHA survey found that 81 percent of hospitals plan to achieve meaningful use of EHRs and take advantage of incentive payments. About two-thirds of hospitals (65 percent) responded that they will enroll during Stage 1 of the Incentive Programs, in 2011-2012.

The NCHS survey found that 41 percent of office-based physicians are currently planning to achieve meaningful use of certified EHR technology and take advantage of the incentive payments. Four-fifths of these, or about a third of all office-based physicians (32.4 percent), responded that they will enroll during Stage 1 of the programs. Only 14 percent of respondents said they were not planning to apply for meaningful use incentives.

Additional survey data from NCHS show that significantly increasing numbers of primary care physicians have already adopted a basic EHR, rising by 50 percent from 19.8 percent of primary care physicians in 2008 to 29.6 percent in 2010. Basic EHRs provide a beginning point for use of electronic health records in physician offices, but most physicians would need to further upgrade their EHR systems or their use of the systems in order to qualify for meaningful use incentive payments.

Incentive payments for the adoption and meaningful use of certified EHR technology were authorized in the Health Information Technology Economic and Clinical Health Act (HITECH) in 2009. Incentive payments will be made through the Medicare and Medicaid programs. High rates of adoption and meaningful use could result in as much as $27 billion in incentive payments over 10 years.

Non-hospital-based physicians and other eligible professionals can obtain incentive payments of as much as $44,000 under Medicare or $63,750 under Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.

Provider registration for the Medicare EHR Incentive Program and some Medicaid EHR Incentive Programs opened Jan. 3, 2011. Most states will allow provider registration to begin for their Medicaid EHR Incentive Programs during the spring and summer of 2010.

"We are pleased to see this evidence of an enthusiastic early response, and we believe participation will continue to grow, especially as the Nation's physicians become more familiar with this one-time opportunity to improve care while helping to offset the costs of adopting EHR systems," said Donald Berwick, M.D., Administrator of the Centers for Medicare & Medicaid Services (CMS).

To qualify for incentive payments, under the Medicare EHR Incentive Program, providers must achieve meaningful use of certified EHR technology, under regulations issued by CMS and ONC. Medicaid providers can receive their first year's incentive payment for adopting, implementing, and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.

Dr. Blumenthal said the meaningful use process has contributed to the increased willingness of providers to adopt EHR systems, especially because it guides providers through staged objectives for the productive use of EHRs, and because providers can now be assured that Complete EHRs and EHR Modules certified under ONC criteria by ONC-authorized testing and certification bodies can be relied upon to support the meaningful use objectives.

He also pointed to the technical support programs created under the HITECH Act and now operating under ONC, which offer support to providers as they switch from paper records to EHRs. In particular, 62 Regional Extension Centers (RECs) across the nation will offer customized, on-the-ground assistance, especially for smaller-practice primary care providers and for small hospitals and clinics.

"We know that adoption of EHRs and conversion to EHR-based care is expensive and challenging, especially for smaller providers," Dr. Blumenthal said. "With HITECH, we are able to provide unprecedented funding and technical support programs to help providers make the transition and to help our nation achieve the improvements in health care quality, safety and cost effectiveness EHRs will bring about."

Dr. Blumenthal also praised medical professional organizations and hospital leaders, who have encouraged members to act soon in taking advantage of HITECH support programs and adopting EHR systems.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

New National Electronic Health Record Safety System Launched

/PRNewswire/ -- A new electronic health record (EHR) safety reporting system was announced today by the iHealth Alliance, a not-for-profit organization composed of medical society and professional liability carrier executives in collaboration with federal agencies and PDR Network. EHRevent.org establishes a national system where physicians and other health care providers can report issues related to the implementation and use of EHRs.

Using a standardized online format, EHRevent will collect reports from physicians and other health care providers who use EHRs and create reports that medical societies, professional liability carriers and government agencies, such as the U.S. Food and Drug Administration (FDA), will use to help educate providers on the potential challenges that EHR systems may bring. The system will be available directly via the Internet at www.EHRevent.org and also integrated into the web sites of participating liability carriers, medical societies, PDR Network and other partners, including EHR system vendors.

EHRevent was modeled after other national reporting systems, including the system used in the aviation industry, and its reports include issues related to software problems, inadequate user training, security breaches and near-misses. Reports will be confidential but used to better understand challenges associated with the adoption and implementation of EHRs and to improve patient safety.

"Electronic health records are being adopted at record rates and present an opportunity to advance patient care," said Nancy Dickey, M.D., iHealth Alliance chair and former president of the American Medical Association. "As with any new system, there is a learning curve for the software providers and for the doctors who use these systems. EHRevent will help us all get smarter about EHRs and assure that patient care advances are also patient-safe advances."

Professional liability carriers who insure doctors against malpractice claims are among the strongest supporters of EHRevent.

"EHRs can impact both the care that is delivered and the record of that care," explained David Troxel, M.D., medical director for The Doctors Company, which is the country's largest professional liability carrier. "EHRs can play a major role in advancing the practice of good medicine, but there are often unanticipated consequences when new technologies are deployed and it is important to collect and disseminate EHR user experience as these powerful systems are adopted."

Alan Lembitz, M.D., vice president of Patient Safety and Risk Management for COPIC Insurance Company, added, "Our experience indicates that EHRs have the capacity either to induce or to reduce medical errors in very unique ways, and we have seen data that indicates that EHR adoption may reduce physician liability. It will be increasingly important to understand best practices to improve patient safety for EHRs and for their users, and EHRevent will help both."

EHRevent is also working directly with EHR vendors as well as Regional Extension Centers (RECs), which are federally designated groups that assist physicians with EHR selection and adoption. Participating EHR vendors and RECs will help educate physicians regarding the importance of EHR event reporting and will receive reports as EHRevent partners.

"Patient safety is at the core of our mission to assist in the adoption of EHRs," explained Kathy Mechler, co-director and chief operating officer for the Texas A&M Health Science Center Rural and Community Health Institute, which includes the CentrEast REC. "We look forward to working with the many EHRevent partners to help educate providers and drive safe EHR adoption."

Michael Stearns, M.D., president and CEO of e-MDs, Inc., a leading EHR vendor, and board president of the Texas e-Health Alliance said, "EHRs have tremendous potential to improve the quality and efficiency of healthcare, but like any tool they must be designed and implemented in a way that uses best practices that strive to eliminate medical errors. We are anxious to collaborate with the EHRevent effort and we encourage all EHR vendors to participate because we believe that EHRevent can be an important communication platform to improve patient safety related not only to EHRs but to medical devices and drugs."

Data collected by EHRevent will also be used by the FDA to help evaluate any safety issues that may arise during the widespread implementation of this technology.

"We applaud the efforts of the iHealth Alliance to help assure the safety of EHRs," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We look forward to working with the iHealth Alliance to encourage physicians and EHR vendors to report information on their experiences with electronic health records to EHRevent and other appropriate reporting systems."

EHRevent and a similar service for reporting adverse drug events via EHRs will be governed by the iHealth Alliance, with network operations provided by PDR Network. PDR Network CEO, Edward Fotsch, M.D. explained, "EHRevent, and RxEvent for adverse drug events, will collect information using online forms that include the Common Format developed by the Agency for Healthcare Research and Quality (AHRQ) and will keep the information confidential through PDR Secure, a Patient Safety Organization, allowing only participating organizations to access the reports.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care," said William Munier, M.D. Director for the Center for Quality Improvement and Patient Safety, AHRQ. "Patient Safety Organizations (PSOs) facilitate a shared-learning approach that supports effective interventions to reduce risk of harm to patients and improve quality. We are collaborating in efforts to facilitate reporting to PSOs those adverse events that are related to EHRs and other health information technology, in order to facilitate the development of safer health information technology solutions."

Starting today, U.S. physicians and other healthcare professionals will learn about and be encouraged to use EHRevent by their medical societies, liability carriers, the FDA, PDR Network and other participating groups.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

ONC Issues Final Rule to Establish the Temporary Certification Program for Electronic Health Record Technology

The Office of the National Coordinator for Health Information Technology (ONC) on June 18 issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Certification is used to provide assurance and confidence that a product or service will work as expected and will include the capabilities for which it was purchased. EHR technology certification does just that: It assures health care providers that the EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.

On March 10, 2010, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) entitled Proposed Establishment of Certification Programs for Health Information Technology. The NPRM proposed the establishment of two certification programs for purposes of testing and certifying EHRs —one temporary and one permanent. The temporary certification program final rule issued today will become effective upon publication in the Federal Register. The final rule for the permanent certification program is expected to be published this fall.

“By purchasing certified EHR technology, hospitals and eligible professionals and hospitals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system,” said David Blumenthal, M.D., M.P.P., national coordinator for health information technology. “We hope that all HIT stakeholders view this rule as the federal government’s commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs.”

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the HITECH Act.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

CMS and ONC Issue Regulations Proposing a Definition of 'Meaningful Use' and Setting Standards for Electronic Health Record Incentive Program

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).

A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of "meaningful use" of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to
public comment.

"Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety," said, National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. "The Recovery Act's financial incentives demonstrate Congress' and the Administration's commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients' experience of care will improve. Over time, we believe the EHR incentive program under Medicare and
Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system."

"These regulations are closely linked," said Charlene Frizzera, CMS acting administrator. "CMS's proposed regulation would define and specify how to demonstrate 'meaningful use' of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule
also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC's regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology."

CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees:
the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.

The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.

The IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use
certified EHR technology to qualify for the Medicare and Medicaid incentives.

Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010.
"We strongly encourage stakeholders to provide comments on these standards and specifications," Dr. Blumenthal said.

The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make "meaningful use" of certified EHR technology. Incentive payments may begin as soon as October 2010 to
eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.

The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and
measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care
coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.

The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed
definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could
request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.

This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers' practice
experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers' capabilities occur.

CMS provides a 60-day comment period on the proposed rule. "The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the
goals Congress established for the EHR incentive programs," Frizzera said.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage

Consumer Watchdog Asks HHS to Repeal Rule Allowing Health Care Providers to Decide When Notification of Breached Electronic Medical Records is Needed

Consumer Watchdog Asks HHS to Repeal Rule Allowing Health Care Providers to Decide When Notification of Breached Electronic Medical Records is Necessary

/PRNewswire/ -- Consumer Watchdog today called on the Health and Human Services Department to repeal a rule that allows health care providers and insurers to decide whether consumers must be notified when the security of their electronic confidential health information has been breached.

In a letter to HHS Secretary Kathleen Sebelius the nonprofit, nonpartisan consumer advocacy group said the HHS regulation violated the intent of Congress when it charged the department with writing the rules requiring notification if electronic medical records are breached. Consumers must be notified whenever there is a breach of medical records, the group said.

The American Recovery and Reinvestment Act of 2009 (ARRA) requires notification if there is an "unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information." The act charged HHS with writing and implementing the rules. But HHS decided to interpret "compromises the security" of data to include a substantial harm standard.

"Under the HHS interpretation, if the breaching entity decides there is no significant risk of financial, reputation or other harm to the individual, the provider or health insurer never has to disclose that the sensitive information was used or disclosed in violation of the federal privacy rule," wrote John M. Simpson, consumer advocate. "In other words, the company responsible for protecting the sensitive data gets to decide if it needs to bother to tell anyone that sensitive health data was breached. This is simply outrageous."

Consumer Watchdog asked what prompted HHS to flout Congressional intent. "Could it be that Congress managed to fend off the pressures of the health care industry in passing ARRA only to have the lobbyists return to exert their influence on the rule making process?"

Read Consumer Watchdog's letter here: https://www.consumerwatchdog.org/resources/LtrSebelius102209.pdf

Consumer Watchdog noted that Rep. Henry Waxman, Rep. Charles B. Rangel, Rep. John Dingell, Rep. Frank Pallone Jr., Rep. Pete Fortney Stark and Rep. Joe Barton have written Secretary Sebelius protesting that the HHS rule violates Congressional intent. The Congressmen's letter said:

"The primary purpose for mandatory breach notification is to provide incentives for health care entities to protect data, such as through strong encryption or destruction methodologies and to allow individuals to assess the level of unauthorized use of disclosure of their information. Such transparency allows the consumer to judge the quality of a health care entity's privacy protection based on how many breaches occur, enabling them to choose entities with better privacy practices. Furthermore, a black and white standard makes implementation and enforcement simpler."

Read the Congressional letter here: https://www.consumerwatchdog.org/resources/LtrCongSebelius.pdf

Consumer Watchdog said that the Federal Trade Commission, charged with writing breach regulations for non-HIPPA covered entities such as Personal Health Records vendors like Google Health did not find any justification for introducing a "harm" standard. "The FTC remained true to Congressional intent and to promoting the public interest," the letter said.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Secretary Sebelius Releases $27.8 Million in Recovery Act Funds to Expand the Use of Health Information Technology

HHS Secretary Kathleen Sebelius today announced awards totaling $27.8 million to health center-controlled networks and large multi-site health centers to implement electronic health records (EHR) and other health information technology (HIT) innovations. The funds are part of the $2 billion allotted to HHS' Health Resources and Services Administration (HRSA) under the American Recovery and Reinvestment Act of 2009 (ARRA) to expand health care services to low-income and uninsured individuals through its health center program.

"The increased use of health information technology is a key focus of our reform efforts because it will help to improve the safety and quality of health care generally while also cutting waste out of the system," Secretary Sebelius said.

"These funds to expand and upgrade electronic health records systems will make a huge difference for health centers struggling to provide health care to the growing number of people in need," said HRSA Administrator Mary Wakefield, Ph.D., R.N.

"Broad use of health information technology has the potential to improve health care quality, prevent medical errors, and increase the efficiency of care provision," added National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. "This program supports the department's overall efforts to assist physicians and hospitals in adopting and becoming meaningful users of health information technology."

Eighteen grants totaling more than $22.6 million will support HER implementation. Grants totaling more than $2.6 million will help four grantees implement a variety of HIT innovations, including the creation of health information exchanges among different providers and the
incorporation of HIT at dental delivery sites. Another five grants totaling over $2.5 million will help health centers devise plans to use existing EHRs to improve patient health outcomes.

HRSA received $2 billion through the Recovery Act to expand health care services to low-income and uninsured individuals through its health center program. To date, more than $1.3 billion of these funds have been awarded to community-based organizations across the country.
HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance.

In addition, HRSA received $500 million in Recovery Act workforce funds --$300 million to expand the National Health Service Corps (NHSC) and another $200 million for other health care workforce programs. The NHSC funds will pay for student loan repayments for primary care medical, dental, and mental health clinicians who will practice for a minimum of two years in NHSC sites that treat underserved and uninsured people. Recently, awards totaling $33 million -- part of the $200 million total were announced to expand the training of health care professionals.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Proposes Mandatory Electronic Safety Reporting

The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.

The agency issued two proposed rules today—one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting. Today’s rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review and archive.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH). “Information obtained from these reports may be critical to future action that improves patient safety.”

Currently, CDRH receives most mandatory medical device adverse event reports on paper, which requires that reports are manually entered into the center’s adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. Not only is this step costly, but it hinders CDRH’s ability to review safety data quickly to uncover potential public health problems.

The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.

The electronic medical device reporting system, known as eMDR, provides a choice of two electronic options for reporting postmarket safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA. Large manufacturers, which can submit hundreds of reports per year, may prefer to use a batch submission protocol, based on a widely recognized informatics standard.

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) currently receive adverse event reports on paper forms or electronically. Safety reporting data submitted on paper forms must be manually entered into the FDA’s Adverse Event Reporting System (AERS) before these data can be evaluated. Since 2000, CDER and CBER have allowed manufacturers (through a pilot program and FDA guidance) to submit adverse event reports electronically, which get quickly entered into AERS. This pilot program has enabled FDA staff to more rapidly review postmarketing safety data and identify emerging safety problems. Safety reports in electronic format can currently be submitted to the FDA either through the FDA’s Electronic Submission Gateway or on CD-ROM, digital tape, or floppy disk. International Conference on Harmonization (ICH) standards for data elements and technical specifications are used for these electronic submissions.

The proposed rule for drugs and biologics reporting would require manufacturers, packers and distributors to submit reports to the FDA in electronic format, which will eliminate manual processing of paper forms by both manufacturers and the FDA. Reports will be submitted to the FDA using either the ICH electronic standards or through an FDA safety reporting Web portal that is currently under development.

“Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,” said Gerald J. Dal Pan, M.D., director of CDER’s Office of Surveillance and Epidemiology.

The proposed rule for drugs and biologics reporting does not apply to safety reports filed under an investigational new drug application, annual reports that manufacturers submit to the FDA on approved drugs and biologics, biologic product deviation reports, reports of complications of blood transfusion and collection confirmed to be fatal, and certain reports on human cells, tissues and cellular and tissue-based products.

The proposed rule for medical devices does not apply to reports submitted on a voluntary basis.

Manufacturers submitting reports under either rule would be required to obtain an electronic certificate to use the FDA Electronic Submissions Gateway. Information on how to prepare and send postmarket safety reports for devices and for drugs and biologics is contained in draft guidance documents. Draft guidance for device reports is available today—draft guidance for drug and biological product reports has been available since June 2008.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page