Saturday, June 2, 2012

FCC gives green light to wireless medical devices

WASHINGTON – The Federal Communications Commission voted today to set aside protected broadband spectrum for wireless medical devices known as medical body area networks (MBANs). These sensors can monitor and read a patient’s vital signs wirelessly. By eliminating the cables that restrict a patient to their hospital bed, experts say the devices could transform the way patients' health is monitored.

The FCC's decision – taken at the suggestion of GE Healthcare and Philips Healthcare, which have been working with George Washington University Hospital on several projects related to MBANs – will set aside spectrum access that is free of transmission interference from Wi-Fi and other high-powered consumer devices.

With this ruling, the FCC has allocated 40 MHz of spectrum – 2360 to 2400 MHz – for use by MBAN devices on a shared, secondary basis. This provides a spectrum band for short-range medical technologies to facilitate reliable low-power operation. The FCC's rule aligns with its National Broadband Plan, which set the goal of advancing several specific "national purposes" including healthcare.

With most patient monitors connecting via cables, some experts say the elimination of those wires could increase a patient’s mobility, helping contribute to improved patient outcomes and enhancing overall comfort.

Small, wearable sensors could collect real-time clinical information such as temperature, blood glucose and respiratory function, and aggregate it at a nearby device for local processing and forwarding to centralized displays and electronic medical records.

GE and Philips officials applauded the FCC's ruling.

"With access to special-purpose spectrum, the healthcare industry's research and development efforts can go into overdrive," said Anthony Jones, chief marketing officer, Patient Care and Clinical Informatics, Philips Healthcare. "The expansion of wireless monitoring capabilities will help allow earlier clinical diagnoses, decisions and interventions, supporting the delivery of better patient care at lower costs."

"The FCC's ruling is the culmination of strong collaboration between the medical industry, regulatory officials and aeronautical stakeholders," added Mike Harsh, vice president and Chief Technology Officer at GE Healthcare. "This is an important inflection point, as it enables advances in miniaturized wireless sensors leveraging the latest chip design and clinical measurement technologies. MBANs could significantly enhance quality and access to patient care, while supporting reduced costs."

[See also: Philips expands clinical informatics portfolio with CDP acquisition.]

MBANs could offer further benefits in the hospital, officials noted:?

Early intervention. Clinicians can catch issues before the patient's condition becomes critical, thus improving patient outcomes while avoiding the need for acute interventional measures.Ease of patient transport. There will no longer be a need to disconnect and reconnect wires prior to transporting a patient.
Infection control. By limiting the wires, MBANs could help reduce the risk of infection and the need for cleaning procedures.
Flexibility. Caregivers will be able to quickly add or remove sensors for different physiological parameters as medical conditions warrant.?

"MBANs represent the next evolution in monitoring a patient's health status," said Richard Katz, MD, director of the Division of Cardiology at George Washington University Hospital. "These wireless innovations can enhance patient safety by giving caregivers the ability to monitor many clinical measurements, wherever the patient is located."

Friday, June 1, 2012

Backers Of Cost-Free Coverage For Birth Control Fault Legal Challenges

Andrew Shaw/iStockphoto.com

You know all those lawsuits now pending around the country charging that the Obama administration's rule requiring most health insurance plans to offer no-cost contraception is a violation of religious freedom?

Well, a whole bunch of supporters of the rule are chiming in now to say that argument has no legal merit.

The dozen new suits, representing some 43 Catholic dioceses, universities and charities "have made a splash by virtue of their number, but when you take a moment to actually look at them, there's nothing to see," Sarah Lipton-Lubet, policy counsel for the American Civil Liberties Union, wrote in a blog post. "The rule is constitutional, it violates no federal law, and it's incredibly important for women."

 

Lipton-Lubet is talking about the rules issued in January (and amended in February to address the religious backlash) that require prescription contraception and sterilization services to be available without additional copays as part of most health insurance packages.

While those filing the lawsuits charge that offering the coverage (or even being forced to facilitate it) in violation of their religious belief runs afoul of the First Amendment's guarantee of freedom of religion, Lipton-Lubet points out that the Supreme Court has already weighed in on the question.

"The Free Exercise Clause does not require any exemptions from a neutral law of general applicability. As the Supreme Court held two decades ago, in an opinion authored by Justice Antonin Scalia, to do otherwise would be to create a system "in which each conscience is a law unto itself." Translation? If it applies equally and doesn't target any faith, it's not a First Amendment violation."

(Backers of the church challenges, however, point to a more recent case, a unanimous ruling this past January, where the justices said religious organizations should have broader hiring and firing power than other businesses.)

But even setting the Supreme Court aside, pointed out Ian Milhiser of the Center for American Progress, more than half the states already require contraceptive coverage. And the issue has already been litigated at that level by the Catholic church � and the challengers lost.

In 1999, in California, Milhiser wrote, "five of the court's six Republican justices held that, even if the law were examined under the strictest level of constitutional scrutiny, California's contraceptive access law is constitutional."

And even if the issues hadn't been litigated before, the current cases are premature, says Nancy Northup of the Center for Reproductive Rights. That's because the work on the regulations remains ongoing.

"This is the most cynical kind of political theater and nothing more," she said in a statement. "Rather than working constructively with the Administration and allowing the rulemaking process to reach a resolution, these groups have chosen to grab headlines with a political stunt that will only burden the courts with untimely claims."

But even though most religious-based organizations will have an additional year � until August 1, 2013 � to come into compliance with the new requirements, some are already taking action.

The 2,800 student Franciscan University of Steubenville in Ohio, for example, announced earlier this month that it would stop offering health insurance coverage for students this fall rather than comply with the mandate.