The two-year race to comply with the patient privacy regulations of the Health Insurance and Portability and Accountability Act (HIPAA) is on. On April 14, Health and Human Service Secretary Tommy Thompson approved the new medical privacy regulations developed during the Clinton Administration. Those regulations now begin a two-year process to full implementation. The rules are considered a victory for consumers, and Thompson emphasized this view. "President Bush wants strong patient privacy put in place now. Therefore, we will immediately begin the process of implementing the patient privacy rule that will give patients greater access to their medical records and more control over how their personal information is used."

Many groups within the health care industry are unhappy with the rule as it is currently written and are hopeful that some changes will be forthcoming. Their hopes may be borne out since Thompson indicated that some of the rules would undergo modifications. Under a barrage of complaints from many groups within the industry, Bush had delayed the original Feb. 26 implementation date in order to collect additional comment. And there were plenty of takers. Thompson said his department received more than 24,000 written comments on the issue.

For its part, the medical device industry is hopeful that more changes will be forthcoming. "At this point it's clear that the administration has heard the concerns and I think, some of the more onerous things regarding consent requirements and so on," said Stephen Northrup, executive director of the Medical Device Manufacturers Association (MDMA; Washington). These requirements, he told BBI, "will probably be addressed by the administration." He said he believes the Bush administration is trying to represent both sides as fairly as possible. "Clearly the president is a strong believer in personal privacy, and I don't think we can argue with that. It's more sort of how do you reconcile that with the need to have data available?"

Availability of product information is also a key issue for the Advanced Medical Technology Association (AdvaMed; Washington), which has charged that HIPAA will create a bureaucracy that will stifle innovation. Janet Trunzo, associate vice president, technology and regulatory affairs, for AdvaMed, said that HHS had added several provisions not in the proposed rule. "The freedom with which covered entities and health care providers communicate with device manufacturers may be infringed upon because of all these complicated requirements that hospitals and physicians may not feel as free to discuss. Ideas and information may not pass through the system as freely as it [now] does."

While Thompson's extension of the comment period seemed to send a signal that the rules could be delayed further or scrapped altogether, this was clearly not the feeling indicated by health care information tech (IT) specialists, as shown in the annual survey of the Healthcare Information and Management Systems Society (HIMSS; Chicago, Illinois). That survey, released following the group's annual meeting in New Orleans, Louisiana, earlier this year, showed that HIPAA has moved to the top of the IT agenda for these professionals, replacing deployment of the Internet as their top concern. Fully 77% of those responding to the survey cited compliance with HIPAA provisions as their No. 1 concern during the next year. Just over half (52%) reported that their organizations have already assessed their compliance with HIPAA (vs. just 37% last year), 44% have documented security policies and procedures (39% last year) and 34% have hired a security officer (27% last year).

The HIMSS survey serves to indicate some clear market opportunities in the health care IT sector. Nearly two-thirds of the health care providers said they will be implementing the use of digital certificates, public key infrastructure or biometric technologies over the next two years to help maintain internal security.

CDRH to get $197.6M for 2002

The Bush administration's proposed budget for fiscal 2002 will provide the FDA's Center for Devices and Radiological Health (CDRH) an 11% increase over the 2001 budget and – what is music to the ears of medical device manufacturers – proposes no user fees for regulatory review of products.

Overall, the center will receive a total of $13.7 million in additional funding, $8.3 million for the center itself and $5.4 million for its field operations. Its entire budget for 2002 is proposed to be $197.6 million dollars, a combination of appropriated funds and non-appropriated revenue sources.

Some of those revenue sources are described under the heading of "user fees," but for CDRH, these fees are charges to importers of medical devices and will support increased inspection of those devices. For both devices and pharmaceuticals, the intent is to limit the importation of infectious diseases and improve overall safety. The CDRH budget calls for an additional $2.8 million for those beefed-up inspection procedures.

Also coming as music to the ears of agency staff is the designation of additional funds for pay raises, with a budget official at CDRH calling these increases "a top priority," and something missing from several recent FDA budgets. "We got a little bit in 1993 and 1994," she told BBI. Since then, she said, the agency has "absorbed upwards of $280 million," balancing small pay raises with staff reductions. The additional monies, she said, would allow the agency, and CDRH, to continue providing service at the same level as 2001, vs. dealing with pay increases through attrition. Overall, the entire agency will get $40 million designated for pay increases.

Besides designating additional funding for pay increases, the proposed 2001 FDA budget designates several other increases for the agency:

$25 million for surveillance of substandard food and health care products imported into the U.S.

$10 million to improve protection of human subjects in clinical trials.

$10 million to improve adverse event reporting.

$17.3 designated to upgrade the agency's "scientific potential and operational efficiency through infrastructure improvements."

FAA puts AEDs on all U.S. airlines

Makers of automatic external defibrillators (AEDs) have a generally common goal: making AEDs as ever-present as fire extinguishers. One more step toward goal was taken last month with an order by the Federal Aviation Administration that mandates installation of AEDs on any U.S. passenger flights staffed by at least one flight attendant. The airlines will have three years to install the equipment on all flights, domestic and international, with the order providing guidelines for flight attendants and other crew to be trained in use of the AEDs. And it estimated the total cost to the airline industry to meet the requirements of equipment and training at $16 million.

In issuing the order, Jane Garvey, FAA administrator, reported that nine airlines already have installed AEDS or have committed to doing so, but she said that the rule "will ensure that all airline passengers have access to this potentially life-saving device." The proposed order was issued by the FAA last May, and the agency received 370 comments on the proposal, 321 described as from the general public and supporting the AED installations and only one comment criticizing the proposal. That comment came from someone describing herself as a registered nurse and saying that any advanced medical care should be delivered by "flight nurses and/or flight paramedics." Twenty-five other comments received, the agency said, supported the proposal "generally" but offered detailed comments or requested modifications.

Among these were statements from AED manufacturer Agilent Technologies (Palo Alto, California), the only organization or company in the medical device and instrumentation sector providing comment on the proposal. Agilent offered several suggestions concerning modifications of the final rules, some of which the FAA agreed with, others not. Most of the other comments in this category came from airlines and worker organizations.

The Air Line Pilots Association (ALPA; Washington) recommended that the AEDs be stored in airplane cockpits to "assure that the flight crew is well aware of the presence of an AED" and to make them more secure. The FAA disagreed, saying that storage in cockpits would make the devices less accessible to attendants. Additionally, it noted four cases of AED batteries rupturing, one of those incidents occurring in a hangared jet. Those incidents, it said, were the result of ruptured batteries powered by lithium sulfur dioxide, with the FAA saying that these batteries "are not intrinsically safe."

The new rules require the addition of several items to the in-flight emergency kit. These are: an oral antihistamine, non-narcotic analgesic, aspirin, atropine, bronchodilator inhaler, lidocaine and saline, an IV administration kit with connectors, an AMBU bag to assist respiration following defibrillation and CPR masks. Various comments suggested adding other supplies, ranging from some types of catheters and nasal cannulas to EKG machines and glucometers. But the agency disagreed with these additions saying that the intent of the rule was to allow additional options rather than to offer a comprehensive list. And it noted that the American Heart Association (AHA; Dallas, Texas) had cautioned against large expansion of the emergency kit materials so as to avoid "simply making available every drug and medical device ever requested by an in-flight physicians."

"According to the AHA, its international guidelines on CPR and emergency cardiovascular care have recommended far fewer resuscitation medications and medical devices than ever before," the FAA said, adding that it will continue to study the inclusion of other kit materials.

A comment from a Teamsters local representing Northwest Airlines (Minneapolis, Minnesota) flight personnel said that air flight emergency kits "include cheap, disassembled parts, with medical equipment manufacturers taking advantage of the air carriers by placing sub-standard equipment in the kits purchased by the air carriers," calling this a problem that "must be addressed." The agency countered this, arguing that current regulations warned against "substandard equipment," that quality equipment "is maintained by routine FAA oversight," and that it had not found evidence of inadequate onboard equipment.

"More than a dozen people are walking around today because defibrillators on American Airlines saved their lives," David McKenas, MD, medical director for the airline, said in a statement.

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