The House passed two small business bills by voice vote Wednesday that may spur technological innovation. The first, H.R. 3738, would create a new early-stage investment program and authorize equity investment financing for small businesses. The bill calls for participating financiers to invest at least half of the funds in early-stage small firms. "This proposal is very well targeted toward companies that drive American innovation and are working to help solve some of our nation's greatest challenges," said TechAmerica President Phil Bond. The second small business bill, H.R. 3014, would authorize $10 billion in loans to be guaranteed to small healthcare practices for access to health IT.
A member of the Health and Human Services Department's health IT policy committee is urging the agency to revise what she argues is an overly broad and unreliable provision of an otherwise solid interim final rule on data breach notification. The Center for Democracy and Technology's Deven McGraw voiced her concern with reporters earlier this week ahead of a Friday meeting of the health IT policy panel. The HHS rule, which is set to take effect Sept. 24, sets data security standards that the agency believes are strong enough to eliminate the need to notify consumers of a data breach -- but its so-called "harm standard" is sub-par, she said.
The interim final rule, which was issued last month, states that a breach does not occur unless the access, use or disclosure poses "a significant risk of financial, reputational, or other harm to individual." In the event of a breach, the rule requires covered entities to perform a risk assessment to determine if the harm standard is met. If they decide that the risk of harm to the individual is not significant, the covered entities never have to tell their patients that their sensitive health information was breached.
The language was not handed down as part of the $19 billion health IT section of the economic stimulus package and was expressly rejected by House staffers who helped craft the measure, McGraw said. She noted its inclusion by HHS is likely the result of lobbying on the part of the healthcare industry. CDT and its allies favor the approach taken by the Federal Trade Commission in its own data breach mandate, which takes effect the same day as the HHS rule. The FTC version stipulates that if an individual authorized the discharge of data, its release is not considered a breach.
The FTC on Monday issued a final rule requiring certain Web-based businesses to notify consumers when the security of their electronic health information is breached. Congress directed the consumer protection agency to issue the rule as part of the economic stimulus package and it applies to both vendors of personal health records - which provide online repositories that people can use to keep track of their health information - and entities that offer third-party applications for personal health records. Such applications include devices such as blood pressure cuffs or pedometers whose readings consumers can upload into their personal health records, the FTC said.
Many existing health IT services are not subject to the privacy and security requirements of the Health Insurance Portability and Accountability Act, which applies to healthcare providers such as doctors' offices, hospitals, and insurance companies. The stimulus package required the Health and Human Services Department to conduct a study and report by February 2010, in consultation with the FTC, on potential privacy and security requirements for vendors. In the meantime, the law required the FTC to issue a breach notification rule. Read details about the rule at www.ftc.gov/healthbreach.
On a related note, security expert Christopher Soghoian is leaving Harvard University's Berkman Center for Internet & Society to work as a technical consultant to FTC's Division of Privacy and Identity Protection in the Bureau of Consumer Protection. On his personal blog, Soghoian noted "the FTC has a lot of really smart lawyers, but they (currently) lack geek skills." He's an interesting hire given his self-admitted penchant for "railing against the oppressive surveillance state and the numerous privacy invasions committed by the law enforcement and intelligence agencies."
NextGov's Bob Brewin reports that:
The top federal panel that sets policies for electronic health records so that a national system can be adopted made recommendations on Friday that would allow multiple organizations to certify electronic record products instead of the one certifying body that exists today. Doctors and hospitals are slated to receive up to $17 billion in stimulus funds to help pay for health information technology systems. But the payments are dependent on doctors using systems that meet "meaningful use" criteria, standards the Health Information Technology Policy Committee is developing.The stimulus package, included in the 2009 American Recovery and Reinvestment Act, required the committee to recommend a policy framework for the development and adoption of a nationwide health information infrastructure -- including standards for the exchange of patient medical information and certifications criteria -- to the Office of the National Coordinator for Health Information Technology at the Health and Human Services Department. Currently, only the Certification Commission for Healthcare Information Technology (CCHIT) certifies electronic health records systems.
Read his full post here.
The heads of three high-tech industry associations sent letters late last week to the chairmen and ranking members of the House and Senate committees currently writing healthcare legislation urging them to avoid technology mandates and ensure "broad, fair, and open competition" among health IT providers. The letter -- signed by Business Software Alliance President Robert Holleyman, Information Technology Industry Council President Dean Garfield, and Jonathan Zuck, president of the Association for Competitive Technology -- outlined a set of principles "to maximize the contributions health IT can make" to improving Americans' healthcare. Read the House letter here and Senate letter here.
"There is near-universal agreement that we can deliver better care less expensively through the use of existing and new technologies. Efforts that would limit new ideas and participants ... should be opposed," they wrote. "We urge you to oppose the inclusion of any explicit or implicit technology mandates in health-related legislation that would prevent ... governments or private parties from considering and procuring the best available technologies in health care management." They said health IT systems should be interoperable; information should be portable; procurement should be inclusive; cost analysis should be comprehensive; security and privacy protections should be a high priority; and usability should be a key criterion.
The Veterans Affairs Department would get $3.3 billion for IT projects to develop electronic health care records, paperless claims systems, and seamless integration of medical and service records with the Department of Defense under the agency's FY 2010 spending bill that passed a key Senate Appropriations subcommittee Monday. Subcommittee passage clears the way for the bill to be considered by the full panel later this week. The broader $133.9 billion bill, which also covers military construction, includes more than $76.7 billion in discretionary funding -- $439 million over President Obama's budget request in discretionary funding. Under the measure, military construction would get $23.2 billion and $53 billion in discretionary funding would go to the VA. A companion bill that passed the House Appropriations Committee last month asks for the same amount for high-tech investments, mirroring Obama's request. "We have done our best to address both the needs of the military and our veterans in this legislation. I remain committed to keeping our promises to our veterans and honoring them by ensuring they receive the care they deserve and require," said Sen. Tim Johnson, D, S.D., who chairs the Senate Appropriations Military Construction, Veterans Affairs Subcommittee.
High-tech and healthcare stakeholders monitoring the implementation of economic stimulus package provisions intended to spur a nationwide network of electronic health records will have their first look Tuesday at what might constitute "meaningful use" of health IT products. A subgroup of the Health and Human Services Department's health IT policy committee will unveil a report on the topic and the full panel will deliberate. The paper will also be released for a formal public comment period and recommendations will ultimately be sent to David Blumenthal, the Obama administration's health IT coordinator. Final HHS guidance will let healthcare providers know how they can qualify for incentives included in the $19 billion section of the American Recovery and Reinvestment Act.
In related news, President Obama spoke on Monday about the importance of moving away from a paper-based healthcare system. He told the annual meeting of the American Medical Association it does not make sense that patients in the 21st century are "still filling out forms with pens on papers that have to be stored away somewhere." "As Newt Gingrich has rightly pointed out -- and I don't quote Newt Gingrich that often -- we do a better job tracking a FedEx package in this country than we do tracking patients' health records," Obama said. He went on to say that patients should not have to tell every new doctor about their medical history nor should they have to endure repeats of costly tests. "All that information should be stored securely in a private medical record," he said.
Senate Commerce Chairman John (Jay) Rockefeller introduced legislation Thursday that he hopes will facilitate nationwide adoption of electronic health records, particularly among small, rural providers. The bill will build upon the use of so-called "open source" e-health records by the Department of Veterans Affairs. Open source software refers to a computer program with unrestricted source code that does not limit the use or distribution by any organization or user. An open source exchange model was recently expanded among federal agencies through the Nationwide Health Information Network-Connect initiative, according to a Friday press release. The economic stimulus package signed by President Obama earlier this year allotted about $19 billion for health IT.
Rockefeller's measure would create a new panel within the Department of Health and Human Service's Office of the National Coordinator for Health IT to direct and oversee formation of this public utility model, its implementation, and operation. It would also implement and administer a new grant program for safety-net providers to cover the full cost of open source software implementation and maintenance for up to five years, with the possibility of renewal for up to five years if required benchmarks are met. Additionally, the bill would ensure interoperability between programs and create a child-specific e-health record to be used in Medicaid, CHIP, and other federal health programs.
"We need advancements in health information technology across the board to improve the quality of care Americans receive," Rockefeller said in a statement. "To make this happen, we need universal access to affordable and interoperable health information technology - from small, rural health clinics to large, urban hospitals." He added that open source software is a cost-effective, proven way to advance health IT. He noted that his bill does not replace commercial software but rather complements private sector investments by making health IT "a realistic option for all providers."
The FTC on Thursday approved a Federal Register notice seeking public comment on a proposed rule that would require entities to notify consumers when the security of their electronic health information is breached. The economic stimulus package included provisions to advance the use of health IT and, at the same time, strengthen privacy and security protections for medical data. Among other things, the law recognizes there are new types of Web-based entities that collect or handle consumers' sensitive health information and some offer personal health records, which consumers can use as an electronic, individually controlled repository for their medical information, the FTC said. Others provide online applications through which consumers can track and manage different kinds of information in their personal health records.
"These innovations have the potential to provide numerous benefits for consumers, which can only be realized if they have confidence that the security and confidentiality of their health information will be maintained," according the FTC press release. To address this, the stimulus bill requires the Department of Health and Human Services to conduct a study and report by February 2010, in consultation with the FTC, on potential privacy, security, and breach notification requirements for vendors of personal health records and related entities. In the interim, the statute requires the FTC to issue a temporary rule requiring entities to notify consumers if the security of their health information is breached. The proposed rule the Commission announced Thursday is the first step in implementing this requirement. Read more about the FTC announcement here.
Acting GAO Comptroller General Gene Dodaro on Friday named 13 members to a health information technology policy committee established by the economic stimulus package. The panel will make recommendations on creating a policy framework to develop and adopt a nationwide health IT infrastructure, including standards for the exchange of patient medical information. The GAO received almost 300 applications for the panel, a spokesman said. An additional seven members will be appointed by the HHS secretary and congressional leaders. President Obama can appoint other members to represent relevant federal agencies.
The stimulus bill also created a standards committee whose members will be appointed by the HHS secretary. The statute does not set a deadline for appointments to that panel, but it specifies the committee must consist of healthcare providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, agency officials, and experts in healthcare quality and security. The Senate has yet to confirm Kansas Gov. Kathleen Sebelius, Obama's pick to lead HHS. David Blumenthal, a former Harvard Medical School professor who has advised Senate Health, Education, Labor and Pensions Chairman Edward Kennedy has been named HHS health IT coordinator.
See a list of the GAO's appointments after the jump and read TechCentral's Issue Of The Week on health IT here.
Surf on over to CongressDaily's TechCentral for a new "Issue of the Week." Here's a taste:
The Department of Health and Human Services is getting ready to meet its first major deadline for setting up one of two key federal advisory committees established within the $19 billion health information technology section of the economic stimulus package. Members of a policy panel charged with making recommendations to the department's health IT coordinator on the implementation of a nationwide system of electronic medical records are due Friday. Thirteen of the committee's 20-plus members are appointed by GAO with additional members selected by HHS and House and Senate leadership.
The stimulus bill allows more time for the formation of the health IT standards committee, whose members are appointed by the HHS secretary with the national health IT coordinator taking a leading role. The time ahead of that deadline, which has not been announced, may help given that the Senate has yet to confirm Kansas Gov. Kathleen Sebelius, Obama's pick for HHS secretary. The Senate Finance Committee will hold its confirmation hearing for her Thursday. Under the statute, the standards committee must consist of healthcare providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant agency representatives, and experts in healthcare quality, privacy and security. Recommendations from the policy panel dictate the work of the standards panel, which has to develop a roadmap by May.
Read the full story here (subscription required).
A couple of tech tidbits from President Barack Obama's first televised primetime press conference, which was also streamed live on the White House Web site:
On the economic stimulus package: "It also contains an unprecedented level of transparency and accountability so that every American will be able to go online and see where and how we're spending every dime. What it does not contain, however, is a single pet project, not a single earmark, and it has been stripped of the projects members of both parties found most objectionable."
On health information technology: "We've got the most inefficient health care system imaginable. We're still using paper. We're still filing things in triplicate. Nurses can't read the prescriptions that doctors -- that doctors have written out. Why wouldn't we want to put that on -- put that on an electronic medical record that will reduce error rates, reduce our long-term costs of health care, and create jobs right now?"
A Santa Monica, Calif.-based group that has been pressuring Google to enhance the privacy and security of its various Web applications slammed the Internet giant Tuesday for allegedly lobbying to allow the sale of electronic medical records in the latest version of the House economic stimulus legislation, which could reach the floor Wednesday. Consumer Watchdog, a newcomer in Washington privacy circles, said Google is reportedly "pushing for the provisions so it may sell patient medical information to its advertising clients on the new Google Health database." A Google spokesman called the claim "100 percent completely untrue and highly irresponsible."
In a letter to Congress that was also sent to President Barack Obama, Consumer Watchdog asked for the removal of what it perceives as loopholes in the package's ban on the sale of patient data and to include other privacy protections currently absent from the legislation. "Medical privacy must be strengthened before the measure's final passage, rather than allowing corporate interests to take advantage of the larger bill's urgency," the letter stated. For its part, Google is not advocating in favor of the sale of health data and is actively supporting strong privacy protections for medical records, the company spokesman said.
Tech Daily Dose previously reported that Consumer Watchdog is entirely funded by the Rose Foundation, which believes that "environmental stewardship, community regeneration, consumer protection, robust civic participation and a healthy economy are all inextricably linked." Its benefactors laid down $100,000 in 2008 to fund a so-called "Google Privacy Rights Project." In other health IT news, the Senate Judiciary Committee heard perspectives on protecting patient privacy in the digital age. Read more in CongressDaily's PM Edition.
On Monday, the New America Foundation will unveil its communications policy agenda for the new administration. Speakers include: FCC Commissioner Jonathan Adelstein; the Consumers Union's Gene Kimmelman; and a number of academics from American University, Carnegie Mellon University, Pennsylvania State University, Rutgers School of Law, the University of San Francisco, and the University of Texas. The Information Technology and Innovation Forum will host a same-day discussion on incentives for broadband deployment in President Barack Obama's economic stimulus package.
The Senate Judiciary Committee on Tuesday will hear perspectives on privacy of personal health records in the digital age. Chairman Patrick Leahy played a key role in the evolution of health IT legislation in the 111th Congress, insisting that safeguards be included in legislation sponsored by Senate Health, Education, Labor and Pensions Committee leaders. The economic stimulus packages making their ways through Congress have health IT components.
Hearing witnesses include James Hester, director of the Vermont State Legislature Health Care Reform Commission; Consumers Union health policy program manager Adrienne Hahn; the Center for Democracy and Technology's Deven McGraw; Michael Stokes, program manager for Microsoft's HealthVault; University of Pittsburgh Medical Center vice president John Houston; and David Merritt of the Center for Health Transformation and the Gingrich Group, which is headed by former House Speaker Newt Gingrich, R-Ga.
On Wednesday, Robert McDowell, temporarily the lone Republican regulator at the FCC, addresses the Media Institute at a luncheon event. Meanwhile, the Information Technology Association of America, which merged recently with the American Electronics Association will recognize Data Privacy Day with a discussion and reception on Capitol Hill.
The House Energy and Commerce and Ways and Means Committees approved their sections of the chamber's economic stimulus package after marathon mark up sessions on Thursday. CongressDaily has two extensive reports that can be accessed here and here (subscription required).
Energy and Commerce Highlights:
• Accepted an amendment by Rep. Bart Stupak, D-Mich, to set a strict timetable for FCC implementation of a formula for distributing broadband money to "unserved" and "underserved" areas.
• Rejected an amendment by Rep. Roy Blunt, R-Mo., that called for areas with no service at all to be helped first, then "underserved" areas.
• Rejected an amendment by Rep. Mike Rogers, R-Mich., to prevent states attorneys from filing suits under federal privacy laws.
• Rejected an amendment by Rep. Michael Burgess, R-Texas, to allow hospitals and doctors to share IT and staff.
• Accepted an amendment from Rep. Ed Markey, D-Mass., to add additional security requirements to protect patients' personal health information.
Just before Washington's collective attention turned to inaugural festivities, House Ways and Means Health Subcommittee Chairman Fortney (Pete) Stark, D-Calif., dropped legislation aimed at overhauling the U.S. healthcare system through advances in technology. Stark introduced a similar bill in the 110th Congress -- much of which was culled from a proposal that emerged from the House Energy and Commerce Committee. His bill would codify the Office of the National Coordinator for Health Information Technology within the Health and Human Services Department; create a more transparent process for the development of health IT standards by the end of 2009; and establish a voluntary certification process for health IT products.
The bill also provides immediate funding for health IT infrastructure, training, dissemination of best practices, telemedicine, inclusion of health technology in clinical education, and state grants to promote the use of electronic medical records. In addition, the legislation provides financial incentives through the Medicare and Medicaid programs to encourage doctors and hospitals to adopt and use certified e-health systems. Physicians would be eligible for as much as $65,000 for showing they are meaningfully using health IT and hospitals would be eligible for several million dollars. Incentive payments would continue for several years but would be phased out over time.
On the privacy front, Stark's bill would establish a federal breach notification requirement for health IT and would let patients request an audit trail showing all disclosures of their health information made through an electronic record. The legislation would change existing laws to include new entities that were not contemplated when federal privacy rules were written as well as entities that do work on behalf of providers and insurers. The measure also would ban the sale of an individual's health information without their authorization and would require providers to attain authorization from a patient in order to use their health IT for marketing and fundraising activities.
The House Appropriations Committee Thursday unveiled an $825 billion economic stimulus package that includes $550 billion in spending and $275 billion in tax cuts to individuals and businesses over two years. The proposal would provide $20 billion for health IT; $6 billion for broadband; $32 billion for smart energy grid investments; and $15 billion for new K-12 school, classroom and laboratory renovation and technology. High-tech and telecom stakeholders cheered the news.
Information Technology Industry Council President Dean Garfield said the package "uses technology to put Americans back to work, creating jobs and new spending at a time when the country needs it most." New investments in electronic medical records, increased spending on science and technology in our nation's classrooms, new and faster reach for broadband and energy efficiency are "sound and sensible ways to jumpstart the economy," he said. He urged the House and Senate to move quickly to pass the legislation.
Stimulus investments in broadband are a valuable first step toward a comprehensive national broadband effort, the Internet Innovation Alliance said. President-elect Barack Obama has shown "tremendous foresight" in recognizing the need for increased deployment and his belief that America should lead the world in broadband penetration, the group said. "Investing in broadband expansion is good for our economy and key to our future competitiveness."
Sen. Barbara Mikulski, D-Md., will chair a hearing of the Health, Education, Labor and Pensions Committee Thursday that will focus on the development of a nationwide system of electronic medical records. HELP Chairman Edward Kennedy and ranking member Michael Enzi sponsored health IT legislation in the 110th Congress but cost and privacy concerns stalled the bill and it never reached the floor. Key Senate staffers have been discussing how such language might be incorporated into a forthcoming economic stimulus package. This is the first in a series of hearings planned by Mikulski who was tapped by Kennedy to lead a Senate work group on improving health care quality.
Witnesses include Jack Cochran, executive director of the Permanente Federation; National Quality Forum President Janet Corrigan; Government Accounting Office IT Director Valerie Melvin; Microsoft Health Solutions Vice President Peter Neupert; and the Health Leadership Council's Mary Grealey. In related news, Booz Allen Hamilton will hold a health IT briefing Monday on a study that calls for "a consumer-centered, quality healthcare system." Speakers include Booz Allen officials and representatives from the Federation of American Hospitals, American Medical Informatics Association and Vanderbilt University.
President-elect Barack Obama on Saturday reiterated his interest in overhauling the nation's healthcare system "to cut red tape, prevent medical mistakes, and help reduce healthcare costs by billions of dollars each year" through the power of information technology. In his weekly radio address, Obama said such changes would "save not only jobs, but money and lives." He also mentioned electronic medical records during a speech in December where he outlined a massive public-works program and a plan to "renew our information superhighway."
In this speech, he said "to make America, and our children, a success in this new global economy, we will build 21st century classrooms, labs, and libraries." Policymakers must enact an "American recovery and reinvestment plan that not only creates jobs in the short-term but spurs economic growth and competitiveness in the long-term," Obama said, adding that it must be designed in a new way. "We can't just fall into the old Washington habit of throwing money at the problem," he said. "We must make strategic investments that will serve as a down payment on our long-term economic future. We must demand vigorous oversight and strict accountability for achieving results."
Obama is scheduled to meet next week with leaders from both parties to discuss his plan. "There is no reason we can't do this. We are a people of boundless industry and ingenuity. We are innovators and entrepreneurs and have the most dedicated and productive workers in the world," he said in the speech, which was also posted on YouTube. "We have always triumphed in moments of trial by drawing on that great American spirit -- that perseverance, determination and unyielding commitment to opportunity on which our nation was founded. In this new year, let us resolve to do so once more."
The Health IT Now Coalition, which represents more than 175 stakeholders including AstraZeneca, Cisco Systems and Pfizer, joined a growing chorus of groups urging lawmakers to include health information technology language in the economic stimulus package that is expected to be finalized after the 111th Congress gavels into session in January (see recent CongressDaily coverage here). The coalition sent a letter Tuesday to members of the House and Senate. The Divided We Fail campaign, which is backed by the AARP, Service Employees International Union and others, also recently asked members for a bailout that includes "significant support" for health IT.
Providing financial incentives for health IT "would not only stimulate economic growth, but would also promote efficiency, improve health outcomes and dramatically reduce health costs for consumers and taxpayers," Health IT Now wrote. "In this economic recession, states are faced with balanced budget requirements at the same time revenues are down and spending on support programs is increasing," the letter explains. Meanwhile, state programs like Medicaid are in need of funds but they often do not utilize health IT to reduce unnecessary tests and procedures and to prevent fraud or abuse, they argued.
Health and Human Services Secretary Mike Leavitt believes interoperability has to be a component of any health information technology language that is considered for inclusion in a forthcoming economic stimulus package. "Before lawmakers act, they need to think: If stimulus money supports a proliferation of systems that can't exchange information, we will only be replacing paper-based silos of medical information with more expensive, computer-based silos that are barely more useful," he wrote in a Washington Post op-ed published Monday.
"Health IT systems produce value when they are interoperable. When they're not, doctors who invest in electronic health records cannot share information with each other or add lab results to your file or send electronic prescriptions to your pharmacist. They would have to use handwritten prescriptions and paper files in addition to their electronic files," Leavitt wrote. "That's not the way 21st-century health care should work." He added that system standards are needed and that those standards should be vendor-neutral.
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