2015 Health IT certification criteria would enhance interoperability

The HHS Office of the National Coordinator for Health Information Technology (ONC) has issued an advance release of a Proposed rule introducing a 2015 Edition of Health Information Technology (IT) Certification Criteria (2015 Edition), proposing a new 2015 Edition Base Electronic Health Record (EHR) definition, and modifying the ONC’s Health IT Certification Program to make it accessible to more types of health IT and health IT supporting various care and practice settings.

The 2015 Edition Proposed rule would also establish the capabilities, standards, and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to achieve meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs).

Background

The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (P. L. 111–5), was enacted on February 17, 2009. The

HITECH Act amended the Public Health Service Act (PHSA) (42 U.S.C. 201 et. seq.) and created “Title XXX – Health Information Technology and Quality” to improve health care quality, safety, and efficiency through the promotion of Health IT and electronic health information exchange. Section 3001(c)(5) of the PHSA (42 U.S.C. sec. 300jj-11) provides the National Coordinator with the authority to establish a certification program or programs for the voluntary certification of health IT.

On July 28, 2010, HHS issued a Final rule adopting the initial set of standards, implementation specifications, and certification criteria and realigning them with the final objectives and measures established for the Medicare and Medicaid EHR Incentive Programs Stage 1 (75 FR 44590), referred to as the “2011 Edition Final rule.”

On September 4, 2012, a Final rule was issued to adopt the 2014 Edition set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for the EHR Incentive Programs Stage 2 as well as Stage 1 revisions (77 FR 54163), referred to as the “2014 Edition Final rule.”

Then, on September 11, 2014, another Final rule was published which revised the 2014 Edition EHR certification criteria to provide flexibility, clarity, and enhance health information exchange (79 FR 54430), referred to as the “2014 Edition Release 2 Final rule.”

2015 Edition certification criteria

HHS’ 2015 Edition Proposed rule builds on this prior rulemaking to facilitate greater interoperability and enable health information exchange through new and enhanced certification criteria, standards, and implementation specifications. HHS believes that these changes will spur innovation, open new market opportunities, and provide more choices to providers when it comes to electronic health information exchange. To achieve these goals, the 2015 Edition Proposed rule would:

  • improve interoperability for specific purposes by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information, including a Common Clinical Data Set composed primarily of data expressed using adopted standards; and rigorously testing an identified content exchange standard (Consolidated Clinical Document Architecture (C-CDA));
  • facilitate the accessibility and exchange of data by including enhanced data portability, transitions of care, and application programming interface (API) capabilities in the 2015 Edition Base EHR definition;
  • establish a framework that makes the ONC Health IT Certification Program open and accessible to more types of health IT, health IT that supports a variety of care and practice settings, various HHS programs, and public and private interests;
  • support the Medicare and Medicaid EHR Incentive Programs through the adoption of a set of certification criteria that align with proposals for Stage 3;
  • address health disparities by providing certification standards for the collection of social, psychological, and behavioral data; for the exchange of sensitive health information; and for the accessibility of health IT;
  • ensure all health IT presented for certification possess the relevant privacy and security capabilities;
  • improve patient safety by applying enhanced user-center design principles to health IT, enhancing patient matching, requiring relevant patient information to be exchanged, improving the surveillance of certified health IT, and making more information about certified products publicly available and accessible;
  • increase the reliability and transparency of certified health IT through surveillance and disclosure requirements; and
  • provide health IT developers with more flexibility and opportunities for certification that support both interoperability and innovation.

The 2015 Edition Proposed rule will publish in the Federal Register on March 30, 2015. Comments on the Proposed rule may be submitted through May 29, 2015.

Highlight on South Dakota: Information announced by Department of Health

New information regarding South Dakota’s tuberculosis control program, oral health progress among grade school children, the reduction of early elective deliveries, and the availability of a web-based health data query system has been announced by the South Dakota Department of Health (SDDH).

TB Control Program

According to the 2014 South Dakota Tuberculosis Control Program Annual Report, during the last 10 years, the state has averaged 14 cases of tuberculosis (TB) per year. During 2014, there were only eight cases reported to the SDDH, which is the second straight year that the lowest number of cases was reported in the state. While the development of anti-TB medications has lead to a decrease in TB cases since the 1950’s, the report concludes that reductions also have been the result of mandatory reporting of suspected cases to the SDDH, case management, new treatment regimens and comprehensive contact investigations to to ensure prompt intervention.

Historically, American Indian TB rates have dropped in South Dakota while white cases have been consistently low. TB cases among black, Asian, and other races in South Dakota mainly represent cases contracted outside the United States that were diagnosed within the state. The majority of TB cases in South Dakota are of African descent, with diagnosed individuals from countries of birth including Afghanistan, China, El Salvador, Indonesia, Romania, Russia, Nepal, Mauritania, Vietnam, South Korea, Bhutan, Kenya, and Palau. South Dakota’s goal was to reduce TB cases to no more than 3.5 cases per 100,000 of population by 2015, and to no more than 15 cases per 100,000 for American Indians by 2015, with both of these objectives having been met.

Nationally, 85 percent of TB cases are reported as pulmonary disease (carried by the lungs) and 15 percent as non-pulmonary.  In 2014, South Dakota reported 2 cases (24 percent) as non-pulmonary sites of disease, i.e., bone, liver, peritoneal, pleural, renal, and lymphatic TB. Because co-infection with HIV is an important risk factor, in South Dakota, all TB cases are offered HIV testing.

Oral Health

According to a 2014 oral health survey of South Dakota children, 56 percent of third graders had experienced dental decay; however, this was a 11 percent decrease from a baseline survey in 2003. The 2014 survey also indicated a decrease in untreated decay (22 percent in 2014), down from 29 percent in 2010. According to the survey, this means that in the 2013-2014 school year, an estimated 2,645 third grade children had untreated tooth decay in South Dakota. One way to prevent tooth decay among children is with evidence-based dental sealants. The survey showed that only 56 percent of third grade children has benefited from dental sealants. American Indian children and children enrolled in the National School Lunch Program had significantly higher prevalence of decay and untreated decay.

Early Elective Deliveries

South Dakota’s First Lady Linda Daugaard announced on March 4, 2015, that 16 of the 24 South Dakota hospitals that perform deliveries have signed pledges to reduce the number of early deliveries done for non-medical reasons. First Lady Daugaard and North Dakota First Lady Betsy Dalrymple had previously challenged birthing hospitals in the two states to reduce early elective deliveries (EEDs).

EEDs are non-medically indicated deliveries performed before 39 weeks of pregnancy for no specific medical reason. According to CMS, EEDs may occur either by induction or cesarean section (C-section), and result in an increased risk of maternal and neonatal death and longer hospital stays for both mothers and newborns, as compared to deliveries occurring between 39 and 40 completed weeks gestation. Due to the health risks to both mother and baby, the American College of Obstetricians and Gynecologists (ACOG) recommends against induced labor or C-sections before 39 weeks of pregnancy unless there is a medical necessity.

A June 2014 data brief from the National Center for Health Statistics (NCHS) reported that the North and South Dakota were among only five states to reduce induction rates at 38 weeks of pregnancy by 30 percent or more, which lead the nation. Improving birth outcomes and the health of infants is one goal of SDDH’s Health 2020 initiative.

Web-Based Data Query System

The SDDH also announced that its Office of Health Statistics has created a new web-based data query system. The system includes statewide and county level health related data. The system provides death and birth statistics from 2000-2012 and cancer incidence and mortality rates from 2001-2011. The Office of Health Statistics plans to update the  site annually. The system includes data based on various demographics such as age, race, ethnicity, and gender.

UK Takes First Step Toward ‘Designer Babies’

On February 3, 2015, Members of Parliament (MPs) in the United Kingdom (UK) debated and passed (by a vote of 382 to 128) a statutory instrument to approve the draft Human Fertilization and Embryology (Mitochondrial Donation) Regulations 2015 in the House of Commons.  Mitochondrial donation is also know as three-parent in vitro fertilization, which effectively allows the conception of babies from three people. Some people fear it is the first step toward creating designer babies, where genetic characteristics could be chosen by the parents. Researchers hope that mitochondrial donation will prevent the passage of mitochondrial diseases from mother to child.

According to a House of Commons research briefing, the mitochondrial donation techniques have been subject to three scientific reviews (2011, 2013 and a further update in 2014) by a Human Embryology and Fertilization Authority (HFEA) expert panel, an ethical review by the Nuffield Council on Bioethics and a HFEA public consultation. The statutory instrument must still be approved by the House of Lords before it becomes law. 

According to the Centers for Disease Control and Prevention (CDC), mitochondria are tiny parts of almost every cell in our bodies. They turn sugar and oxygen into energy that the cells need to work. In mitochondrial diseases, the mitochondria cannot efficiently turn sugar and oxygen into energy, so the cells do not work correctly. There are many types of mitochondrial disease, and they can affect the brain, kidneys, muscles, heart, eyes, ears, and other parts of the body.

To prevent the passage of mitochondrial disorders from mother to child, researchers have devised the mitochondrial donation process by which the nucleus of a woman carrying harmful mutations in her mitochondrial DNA is transferred to an enucleated egg (an egg with the nucleus surgically removed) of another woman without such defects. The hybrid egg, which carries the nuclear DNA of the mother-to-be and healthy mitochondria from the egg donor, can then be fertilized in vitro with sperm from the would-be father, and the resulting embryos implanted into the mother-to-be.

The BBC reported that the Church of England and the Catholic Church in England and Wales urged UK politicians to delay their decision in order to allow more research and debate. The BBC quotes the Reverend Doctor Brendan McCarthy, Church of England advisor on medical ethics, as saying “We need to be absolutely clear that the techniques that will be used will be safe, and we need to be absolutely sure that they will work.” Sharon Bernardi, who lost all of her seven children to mitochondrial disease, told the BBC that this was not about changing the color of a child’s eyes. “This is [about] trying to make children survive,” she said. “We are not playing God or anything. I would ask them [the Church of England] desperately to please look at the bigger picture and look at the children who have been affected by the dreadful disease. No child should be born with a disease that’s going to cut their life short. I can’t believe anybody from the Church would want that.”

In the United States, on February 25-26, 2014, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee conducted two days of hearings on the topic of mitochondrial donation (specifically, oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility). The advisory committee panel discussed what controls might be used in trials, how a developing embryo might be monitored during those tests, and who should oversee the trials. No decisions were made at the end of the session.

 

If You Operate 20 or More Food Vending Machines, Here is What You Need to Know

The FDA believes that by requiring vending machine operators to provide accurate and clear calorie information for food sold from their vending machines, consumers will be able to make more informed and healthy dietary choices. To that end, on December 1, 2014, the FDA implemented the vending machine food labeling provisions contained in section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA) (P.L. 111-148) by establishing requirements for providing calorie declarations for food sold from certain vending machines. Section 4205 of the ACA added section 403(q)(5)(H)(viii) to the Federal Food Drug & Cosmetic Act (21 U.S.C. sec. 343(q)(5)(H)(viii)).

The new regulations (21 C.F.R. 101.8), not effective until December 1, 2016, apply only to “vending machine operators” who own or operate 20 or more “vending machines” or who register with the FDA and voluntarily agree to be subject to the new requirements.

To determine if the requirements are applicable to a person or entity, they must first determine if their machines are “vending machines” and whether they are a “vending machine operator” under the FDA’s definition. If they determine that they are a vending machine operator with 20 or more vending machines under the FDA definitions, then they must abide by the rules governing the location and format of the calorie declaration, the disclosure of contact information, and the maintenance and availability of certain records. The failure to comply with the calorie declaration requirements will render the food in the vending machines adulterated under section 403 of the FD&C Act (21 U.S.C. 343).

Definitions

Under the new regulations,  a vending machine is defined by the FDA to mean “a self-service machine that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses servings of food in bulk or in packages, or prepared by the machine, without the necessity of replenishing the machine between each vending operation.”

According to the FDA, this definition of vending machine could encompass, but is not limited to, vending machines that sell soft drinks, packaged snacks, hot-and-cold cup beverages, refrigerated prepared food (such as those sold from turnstile vending machines), and handfuls of nuts or candies (such as those sold from bulk vending machines). Game machines are excluded from the definition, even if they sometimes dispense candy or other edible items as part of the game.

A vending machine operator is defined as “a person or entity that controls or directs the function of the vending machine, including deciding which articles of food are sold from the machine or the placement of the articles of food within the vending machine, and is compensated for the control or direction of the function of the vending machine.”

Location of Calorie Declaration

If the food sold from the vending machine permits the consumer to examine the Nutrition Facts label before purchase, or otherwise provides visible nutrition information at the point of purchase (such as through front-of-pack calorie labeling), then no further calorie declaration is required. For all other articles of food that do not meet this criteria, the vending machine operator must provide calorie declarations on a sign (which can be a sticker) close to the article of food or selection button (i.e., in, on, or adjacent to the vending machine). The sign does not need to be attached to the vending machine as long as the calorie declaration is visible at the same time as the food, its name, price, selection button, or selection number is visible. Electronic or digital display of the calorie information is also permitted.

Calorie Declaration Format

Generally speaking, the calorie declarations must be clear, conspicuous and prominently placed. When the calorie declaration is in or on the vending machine, it must be:

  • in a type size no smaller than the name of the food on the machine, the selection number, or the price of the food as displayed on the vending machine, whichever is smallest;
  • displayed with the same prominence, meaning the same color, or a color at least as conspicuous, as the color of the name or price of the food or selection number; and
  • set against the same contrasting background, or a background at least as contrasting as the background used for the item it is in close proximity to, i.e., name, selection number, or price of the food item as displayed on the machine.

When the calorie declaration is on a sign adjacent to the vending machine, the calorie declaration must be (1) in a type size large enough to render it likely to be read and understood by the consumer under customary conditions of purchase and use, and (2) in a type that is all black or one color on a white or other neutral background that contrasts with the type color.

Vending machine operators may rely on a number of ways to determine the calorie content for foods sold in their vending machines, including the food package’s Nutrition Facts Label, the manufacturer or supplier of the food, nutrient databases, cookbooks, or laboratory analyses.

Recordkeeping

The FDA expects vending machine operators to generate and maintain a record of the information regarding how they determined the calorie content for their vending machine foods. Operators should be prepared to share the record of information with the FDA during an inspection if the agency needs to determine whether the posted calorie declarations are truthful and not misleading.

Enforcement

The FDA is requiring vending machine operators to disclose their contact information on their vending machines. This information must include the operator’s name, telephone number, and mail or email address. The agency plans to use this information to contact operators for enforcement purposes. The failure to comply with the calorie declarations requirements will render vending machine food misbranded under the federal Food, Drug & Cosmetic Act.

FDA Guidance

In August 2010, the FDA issued guidance titled “Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws.” The guidance was last updated on July 9, 2014. Additional information can be obtained from the FDA’s Menu and Vending Machines Labeling Requirements webpage, which was updated on December 2, 2014.