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Prototype Firewall Could Prevent Malicious Medical Device Hacking

As researchers continue to expose the security vulnerabilities of current insulin pumps, pacemakers, and other software-controlled devices, pressure is mounting for solutions that can protect patients if such attacks are launched in the real world. After demonstrating the ability to reverse engineer an insulin pump, a group of researchers from Princeton University (New Jersey) and Purdue University (West Lafayette, IN) has developed MedMon, a prototype firewall that could act as a viable safeguard against wireless medical device hacking.

"It was surprisingly easy to hack into the insulin pump. It appears that many of these devices were not designed with security in mind, so [the pump] was very vulnerable," notes Niraj Jha, a professor of electrical engineering at Princeton. "The advantage of having an insulin pump far outweighs such a risk. But for the next generation of devices, it would be good to have other defenses built into medical devices."

Attempting to offer such a defense against malicious medical device hacking, the researchers created the MedMon firewall. Providing multilayer anomaly protection, the prototype system is designed to safeguard devices against both physical and behavioral anomalies through wireless monitoring of the patient. In terms of physical anomalies, Jha explains, the system can identify a possible attack by recognizing changes in physical signal characteristics. Signals that fall outside of a particular range or come at a different time interval or angle can indicate a security threat, for example.

"If it's a sophisticated attacker and he knows our methodology, he could try to fool the system by transmitting with similar signal characteristics to legitimate transmissions," Jha notes. "We then have another layer of protection, called behavioral anomaly detection, where we are protecting command and data anomalies. So, if someone is trying to cause multiple or higher dosages to be administrated to the patient that's beyond the [acceptable] range, we detect that through behavioral anomaly detection."

MedMon also features both a passive and an active mode. A security breach that does not endanger a patient, for instance, will simply trigger an alert to make a patient aware of the issue. However, attempts to manipulate control or data will prompt the firewall to intercept and actively jam the suspicious signal so that it does not reach the medical device, according to Jha.

Although the researchers have achieved a proof of concept, a commercial version would need to be miniaturized. If commercialized, the technology could offer a stand-alone security solution to current software-controlled medical devices. The firewall system could be marketed directly to patients and either attached to a smartphone, kept in a patient's pocket, or worn on the body to protect implanted or body-worn medical devices. Alternatively, medical device manufacturers could begin packaging MedMon as a separate security unit with current wireless devices in the near term. In the future, they could potentially integrate the firewall directly into next-generation devices.

"No security system is absolutely foolproof, but I think our system certainly raises the bar for attackers," adds Anand Raghunathan, a professor of electrical and computer engineering at Purdue. "The risk of such attacks is low, but they are certainly cause for concern. Our objective is to make sure that these laboratory attacks are never successful in the real world."

Firm Leverages Raspberry Pi for Medical Controller Applications

Because of the stringent medical device regulatory environment, the longevity and consistency of products and processes from suppliers is a primary concern of medical device manufacturers. Finding a creative way to accommodate this need, medical electronics manufacturer Emblation Microwave (Alloa, Scotland, UK) is leveraging an open, educational training platform dubbed Raspberry Pi as a robust medical controller platform to satisfy long-term device requirements.

Developed in the UK, the Raspberry Pi platform was designed as an affordable, educational platform intended to stimulate interest and enhance skills in computer science among the next generation of designers and engineers. Despite being a credit-card-sized, single-board personal computer, the platform can perform many of the same tasks as a traditional PC. For example, it is equipped with suitable networking, word-processing, graphics, and high-definition video capabilities.

Recognizing the potential of the platform to provide more than educational support, however, Emblation is exploiting such advantages as flexibility in programming options, low cost, uniformity, and longevity for use in medical device applications. "There are other options [for embedded controller systems], but the problem is that they routinely get upgraded or change in some way," observes Eamon McErlean, technical director at Emblation. "In medical devices, you want consistency; you want to design on a platform that, over time, will be robust and not change very much. Raspberry Pi has the potential to do that." Validation of a new controller platform to replace an obsolete unit is, after all, a time-consuming and inconvenient process, McErlean adds.

Another key advantage of Raspberry Pi, according to McErlean, is that it provides some flexibility in terms of the operating system--an important consideration for computer-controlled medical device applications. The Raspberry Pi foundation states that Fedora is the recommended distribution for the platform. However, users can replace the root partition on the secure digital card with another ARM Linux distribution, if preferred.

Although Emblation is initially employing Raspberry Pi as a control platform to support its own microwave generators, it intends to someday release the controller technology directly to medical device OEM customers. Following the model established by suppliers of medical-grade power supplies, the company states that it would potentially provide a turnkey hardware pack, consisting of a documentation and hardware pack to ensure compliance to IEC 60601 standards. Medical device manufacturers would be responsible for validating their own software, however. Applications for the controller system include imaging systems and electrosurgical products, among others.

"Raspberry Pi," McErlean notes, "has the potential to cope with quite complex programs as well as simple programs and [features] the communications and control capabilities of a larger computer."

The Sunshine Act's Sphere of Influence | Medical Device Podcast

It is well known that medical device companies rely heavily upon input from physicians to help identify and develop new ideas for innovative medical devices. But how will the impending Sunshine Act affect the relationships between manufacturers and physicians? Are there any loopholes? As a medical device professional, what else should you know about the Sunshine Act?
 

Amy Dow, Epstein Becker Green

In this interview, Amy Dow, attorney with Epstein Becker Green, helps us understand the requirements of the Sunshine Act and the issues surrounding its implementation. Amy currently represents medical device, pharmaceutical, and biotech companies on a wide variety of compliance and regulatory matters and is considered a leading expert on the Sunshine Act. Read on for her thought-provoking insight regarding the potential ramifications of the Sunshine Act.

What You Will Learn:

  • What exactly is the Sunshine Act? Its purpose, scope, major requirements.
  • The origin of the Sunshine Act and will we ever see it actually come to fruition?
  • Ramifications of the Sunshine Act for medical device companies. Amy covers the two major issues: Resource constraints and the short 90-day window.
  • How will the Sunshine Act affect physicians and hospitals? Also, will it impact small medical device companies the most?
  • What problems is the Sunshine Act trying to solve? Perhaps more importantly, will patients actually care? And will they even be able to decipher the Sunshine Act data?
  • Payment requirements that medical device companies need to consider in light of the Sunshine Act.
  • Two other problems that medical device companies may face when dealing with the Sunshine Act: 1) Associated link between payment and product; 2) The delayed research factor.

Listen to the "The Essential Elements of the Sunshine Act and the Corresponding Impact on Medical Device Companies" podcast (right click and select "Save Link As" to download the podcast).

Download the PDF action points of the "The Essential Elements of the Sunshine Act and the Corresponding Impact on Medical Device Companies" podcast.

Ceramics Nanotechnology Enables Development of Disease-Detecting Breathalyzer

Breathalyzer technologies designed for diagnostic functions have generated a great deal of interest in recent years, promising detection of everything from cancer to the onset of an asthma attack from one sample breath. Now, a research team at Stony Brook University (New York), with support from the National Science Foundation, has developed a nanotechnology-based single breath disease diagnostics breathalyzer that it hopes could someday provide patients with an affordable means of managing their care and obtaining early detection of various diseases.

Enabled by the use of ceramics nanotechnology, the breathalyzer tests a sample of exhaled air for a disease biomarker and provides an instant readout. Results are simple and easy to understand; a green light means that there is no sign of an underlying disease while a red lights indicates that the patient should see a physician because of the presence of a disease biomarker.

And driving this exciting development is a sensor technology that is coated with tiny, electrospun, single-crystal nanowires. "These nanowires enable the sensor to detect just a few molecules of the disease marker gas in a 'sea' of billions of molecules of other compounds that the breath consists of," says Perena Gouma, a Stony Brook professor involved in the project.

"There can be different types of nanowires, each with a tailored arrangement of metal and oxygen atoms along their configuration, so as to capture a particular compound," she adds. "For example, some nanowires might be able to capture ammonia molecules, while others capture just acetone and others just the nitric oxide. Each of these biomarkers signal a specific disease or metabolic malfunction so a distinct diagnostic breathalyzer can be designed."

The breathalyzer could be adapted to perform these tests, including detection of acetone as an indicator of diabetes or ammonia as a way to help determine when to end home-based hemodialysis treatment. However, the researchers anticipate that the device will eventually be capable of performing a number of biomarker-detection tests within a single breathalyzer device.

If commercialized, the product could potentially be marketed directly to consumers at a price point below $20. "People can get something over the counter and it's going to be a first-response or first-detection type of device," Gouma says. "This is really a nanomedicine application that is affordable because it is based on inexpensive ceramic materials that can be mass produced at low cost."

Minimally Invasive Device Market Poised for Continued Growth

Minimally invasive devices and surgical tools have flooded the market in recent years in response to the surging demand for medical devices and procedures that can reduce risk, trauma, and recovery time for patients. In light of the overwhelming success of such medical devices, the global minimally invasive surgical market was estimated at $23 billion in 2011 with an approximate annual growth rate of 8% during the next five years, according to a report by global market research and consulting company MarketsandMarkets.

The report, "Minimally Invasive Surgical Instruments, Imaging & Visualization Systems and Medical Robotics Market (2011-2016)," examines the major global market drivers, restraints, and opportunities for these devices during the next five years. Led by such major multinational medical device companies as Intuitive Surgical, GE Healthcare, Philips, Siemens, and Covidien, the worldwide market for minimally invasive devices is predicted to reach $35.5 billion by 2016.

Although broad, the minimally invasive device market is primarily composed of such device-classification areas as handheld instruments, guiding devices, inflation systems, auxiliary devices, ultrasound, x-ray, CT and MRI imaging, electrosurgical devices, and robotic-assisted surgery systems. Minimally invasive surgical devices, however, represent the lion's share of the market. They were estimated at $9.2 billion in 2011 and are forecasted to hit $11 billion by 2016, according to the report.

"A large number of technological innovations in the devices used in such procedures have been seen in the past years, with newer devices coming up with better safety and efficacy attributes contributing to widespread adoption of the minimally invasive procedures by physicians worldwide," according to the report. "Although widespread investment in research and development for MIS is still poor, venture funding will have a tremendous impact on the overall revival, as economic conditions improve gradually."

IVD Market to Exceed $9.5 Billion by 2017

Breakdown of the current IVD market
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth.
The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow.
Overall market growth will be driven by the increasing prevalence of chronic diseases in the U.S. population, many of which require IVD testing. Therefore, over the forecast period, the market is expected to grow at a compound annual growth rate (CAGR) of 2.5% by 2017.
High Specificity of Molecular Testing Drives Market Growth. The molecular diagnostics market is expected to grow as more assays become FDA approved and testing shifts to molecular methods from microbiology or immunoassay disciplines. (See Figure 1.) Molecular diagnostics involves tests for detection of nucleic acids, including DNA, RNA, and related proteins. The main areas of molecular diagnostic testing include infectious disease, genetic disease, and oncology testing.
Traditional testing methods to detect proteins lack the sensitivity necessary to detect minute amounts of protein that may be present in early stages of disease. Current methods include chemiluminescence and enzyme-linked immunosorbent assay (ELISA), which require higher concentrations of protein biomarker. Thus these methods are only effective once the disease has progressed. As early detection of disease becomes more important, more sensitive methods, such as molecular testing, will gain popularity. Molecular testing methods can detect protein at concentration levels hundreds’ less than current immunoassay techniques, thus enabling earlier detection of disease and more-accurate monitoring of disease progression.
The infectious-disease assay market will be driven by development of new assays for different diseases and conditions. Growth experienced a spike in 2010 due to the introduction of an FDA-approved assay for Herpes Simplex Virus (HSV; see Figure 2). Therefore the market for molecular diagnostics will grow at a CAGR of 2% to exceed $2.38 billion by 2017.
Point-of-Care Testing Continues to Grow Despite Uncertainty from Healthcare Reform. Point-of-care (POC) testing is defined as medical testing at or near the site of patient care. POC testing may also be done in alternate care settings including radiology/imaging centers, surgical centers and primary care and allows the physician to receive and deliver results in a shorter period of time than traditional laboratory testing.
IVD market annual growth rate
The market for molecular diagnostics experienced a spike in 2010 due to the introduction of an FDA-approved assay for Herpes Simplex Virus.
In 2010 healthcare reform legislation was implemented in the United States. Uncertainty as to the scope and changes that might result in healthcare caused many hospitals and physician office labs to delay equipment purchases. An annual excise tax on the sale of medical devices is expected to start in 2013. This may result in manufacturers getting customers to absorb the extra cost, thus increases in ASP and delays in new purchases are anticipated. However, strong growth in unit sales is expected at a CAGR of 6.1% over the forecast period, as physicians become more aware of the many benefits of POC testing.
Global Powerhouses Siemens and Roche lead U.S. Market. The IVD market is highly segmented, as many niche players hold market share in market sub-segments. (See Figure 1.) However, large international players such as Siemens, Roche, Beckman Coulter, and Abbott held significant shares due to their brand recognition and comprehensive portfolios.
In 2010 the leading competitor in the IVD market was Siemens Healthcare Diagnostics. It competed in five of the six market segments and was also the leader in the immunochemistry and hemostasis markets. Siemens offers a broad spectrum of products that can be used in conjunction with their solutions for automation and informatics.
In October 2010, Siemens announced a new three-year agreement with Premier Purchasing Partners, LP, the group purchasing unit of Premier Inc., for hemostasis, urinalysis, and microbiology systems and reagents. They are responsible for device purchases for more than 2400 member hospitals and nearly 70,000 additional healthcare sites in the United States. This contract will further increase Siemens' penetration in the hemostasis and urinalysis markets.
The second leading competitor was Roche Diagnostics. It was the leading competitor in the POC testing and molecular diagnostics markets, as well as the second leading competitor in the blood donor screening and immunochemistry markets.
In the POC testing market, Roche launched the Cobas b 123 POC system multi-parameter blood-gas analyzer for use at the point of care and in laboratories last year. Roche also launched several new products in 2010 within the molecular-diagnostics bloodborne virus assay market segment.
 
The information contained in this story is taken from a comprehensive report published by iData Research (www.idataresearch.net), “U.S. In Vitro Diagnostics.” For more information and a free synopsis of the report, readers can contact iData Research at [email protected]

Women in Medtech: Lisa Suennen Is on a Mission to Help Align Financial Incentives in Healthcare

Lisa SuennenLisa Suennen is the managing member and co-founder of Psilos Group (Corte Madera, CA), a healthcare-based venture capital firm that has nearly $600 million under management. When asked what her job description is, Suennen offers a simple summary: “take smart investors’ money and give them back more while leaving great companies in our wake.”

Suennen became a venture capitalist in the healthcare space after holding a number of senior executive roles at Merit Behavioral Care. Before that, she worked in the technology industry, which she notes was unfulfilling for her. “Maybe it was the sector I was in, but technology for technology’s sake was not interesting in terms of thinking about what I am going to leave behind. I wanted to work for a company that also makes a difference in people’s lives,” she says. “While gaming, mobile phones, and things like that are important, they are not what you are going to think about on your deathbed,” she says. “By contrast, healthcare is very tangible to me. Everybody deals with their health every day.” And working with healthcare companies gives her “an opportunity to do well by doing good.”

“Healthcare is very tangible to me. Everybody deals with their health every day.”

In her current position, Suennen has the opportunity to work directly with entrepreneurs and executives in the medical device, health information technology, and healthcare services industries. Suennen also serves on the board of directors for a number of those companies, including AngioScore, PatientSafe Solutions, OmniGuide, and VeraLight. Each of these companies has launched products that have proven it is possible to improve care while reducing costs and improving patient safety to the healthcare system across a multiplicity of medical sectors from cardiology to gynecology to diabetes, as well in the delivery of safer hospital-based care.

Suennen, whose nom de blog is “Venture Valkyrie,” regularly writes about healthcare investing for a number of sites including her own (www.venturevalkyrie.com), The Health Care Blog, and CNN Money. She also regularly speaks at conferences on the topic of healthcare investing.

MD+DI: How did you get started investing in healthcare companies?

Suennen: Career-wise, I started in high tech, which I found to be profoundly unfulfilling. My dad was a healthcare entrepreneur and the inventor of real-time ultrasound. He and I were talking and he said, “you know, I think that healthcare would really give you more of that fulfillment that you are looking for.” So I ended up joining a start-up company, which was a managed behavioral healthcare company known as Merit Behavior Care. And that start-up became an $800-million per year company. Along the way, my dad ended up becoming the CEO, which was sort of a weird but great outcome.

When we sold the company, he and our investment banker and I created Psilos. Our original focus was on healthcare services and healthcare IT. But my dad had a background in medical devices and I had done some work in that area back in my first career with public relations and I personally had a very strong interest in that sector of healthcare. When we started the fund we decided we were going to specialize in the concept of technologies and services that reduce the cost of healthcare, improve quality, and align the incentives among patients, payers, and providers. We felt that this thesis applied broadly across healthcare IT, healthcare services, medical devices, and diagnostics and thus we diversified into those latter sectors as well. That is the genesis of my current career. I’ve been now working 14 years in the healthcare venture capital area and it is great.

MD+DI: What are the main challenges you see working in venture capital investment in healthcare?

Suennen: Healthcare is definitely the poor stepchild in venture capital. For reasons I don’t understand, it is not as sexy as social networking, digital media, or clouds. It is definitely not the number one thing people want to invest in. And yet is literally our biggest economic challenge for this country and one of the few things every human has in common to worry about. I have a hard time reconciling that disconnect. But companies are perceived to be harder to build in healthcare than in other sectors because of the regulatory, reimbursement, economic, and human issues.

[Healthcare] is literally our biggest economic challenge for this country and one of the few things every human has in common to worry about.”

In healthcare, economic incentives are so misaligned. Consider the triangle of the patient, provider, and payer. A new product that helps one of those players, most of the time, disadvantages one of the others. And the disadvantaged players don’t like that. So you have to think very hard about aligning the incentives; when they are not aligned the enterprise has a very hard time prospering in the current environment.

Let me give you an example of how the incentives can affect each other: Let’s say you are introducing a new medical device that moves surgeries from the hospital to an outpatient setting. Some hospitals would lose money as a result of that shift. Insurers might like it because, on the one hand, it might be a less expensive procedure with no hospital stay. But they might also be worried that there will be a lot more of them because they are easier to do. So, in the end, it may cost the payer more. At the same time, the patient may like the fact that the procedure is less invasive or and no hospital stay is needed. But on the other hand, if their favorite provider doesn’t perform that procedure in an outpatient setting or isn’t adept at the minimally invasive surgical approach, they can’t take advantage of that procedure unless they pay for it out of pocket or without more significant clinical risk.

So in healthcare, things that may appear intrinsically good aren’t always either good or welcomed. And that fundamental misalignment of financial and clinical incentives is endemic to healthcare and to no other industry except maybe higher education. There is also a disconnect in that the person receiving the services (the patient) usually has no idea what is best for them, no way of judging that and also no information whatsoever about the cost benefit of alternative interventions. And that is why our investment strategy is about finding things that align financial incentives because those are the types of things that succeed.

MD+DI: What advice would you give to people looking to get into this field?

Suennen: My advice for someone who wants to be a VC in the healthcare space is two fold: first, bring a focus on healthcare economics. The healthcare system is not currently rewarding science and technology innovations that add cost to the system or are just incremental improvements. Second, bring a lot of intestinal fortitude; despite the burning market need for innovation in healthcare, it is not currently a favored sector. Even when it works, companies take a very long time to mature to full value. This is not a job for wimps, that's for sure.

MD+DI: Are there barriers to women entering the healthcare investing? How can they be overcome?

We need to encourage women entrepreneurs to come forward and build great businesses to enhance the flow of women into healthcare investing.

Suennen: The biggest barrier right now is that this is an industry that is downsizing. This makes it harder for both women and men to break in. Women are actually leaving the field in greater numbers because they generally have less seniority, so it is a real challenge. The best way for women to enter the healthcare venture capital field is through garnering great senior level operating experience and delivering returns to their own investors while networking with the people already in the field—male and female.

MD+DI: How can we get more women involved in healthcare investing?

Suennen: We need to encourage women entrepreneurs to come forward and build great businesses to enhance the flow of women into healthcare investing. That is the usual career path: successful company executive to VC. Women also have to get better at advancing their own careers by packaging and marketing themselves actively to the male incumbents. Too often women downplay their accomplishments and this isn’t a field that values modesty.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

CMS’s Unprecedented TAVR Decision

CMS’s Unprecedented TAVR Decision

Scott Gottlieb, MDWhile Centers for Medicare & Medicaid Services (CMS) recently decided to cover transcatheter aortic valve replacement (TAVR), the agency outlined specific restrictions with respect to its use in patients with symptomatic aortic stenosis. In many ways, those conditions are unprecedented, said Scott Gottlieb, MD, a resident fellow at the American Enterprise Institute.

Gottlieb, who is a practicing physician who has also served as a senior policy adviser at CMS, is surprised that the watershed decision hasn’t received a greater amount of attention. “It shows CMS becoming, I think, far more aggressive than it has been in the past,” he says. “And in a lot of respects, CMS is behaving in this context like a traditional insurer.”

“Whereas, the traditional insurer can require certain things and people can opt for different policy plan, when CMS [makes a decision], you don’t have any option,” he explains. “If you are an institution and Aetna says you have done something to get coverage, you can make a decision if you want to get coverage from them or not,” he adds. “But if you are an institution and CMS puts in place certain requirements, you have no choice. So it ends up setting up the standard for the entire marketplace.”

Gottlieb believes that the recent CMS decision could be a harbinger of how Washington will begin taking over increasing control of healthcare in the United States in its efforts to curtail costs. “When [CMS sees] high-cost procedures that fit that potential profile, they try to put in place restrictions—not dissimilar to what they did with the implantable defibrillators,” he says. “Ultimately, it is sort of a game of whack-a-mole because most people think that the indication for minimally invasive aorta repair is going to get expanded over time. But I guess the agency is doing what it can to try and restrict utilization and cost at this point.”

Some of CMS’s efforts to cut costs could have the opposite effect, he says. “They are requiring a cardiothoracic surgeon and an interventional cardiologist to be on hand when the procedure is done,” he says. “You could really argue that a good interventional cardiologist should be able to handle this procedure solo. So by requiring both physicians on hand, you are actually increasing costs.”

The decision also marks the first time that CMS has required coverage with evidence development for the labeled indication. “They are requiring rigorous post-market studies—not just registries for the unlabelled uses,” he says. “They are requiring manufacturers to pay for the studies, even though they are turning it over to a third party to do.”

Such studies would presumably be used to expand the label, Gottlieb explains, “so now the manufacturers are going to have to try and negotiate how they both satisfy FDA and CMS at the same time. These are sort of unprecedented issues. CMS is making a lot of new policy in the context of this decision,” he adds.

Gottlieb predicts that the decision will lead some patients in the United States to go to Europe to have the TAVR procedure done. Alternatively, they could just pay for it out of pocket in this country. “A lot of patients aren’t going to want to have an open procedure when they can have a minimally invasive one,” he says.

Key Stakeholders: The Medical Device Tax Should Be Implemented Responsibly

AdvaMed and a collection of healthcare groups have submitted separate comments to IRS regarding the implementation of the medical device tax, which is slated to go into effect in January 2013. While AdvaMed continues to work to have the device tax repealed, if the tax does go into effect, it hopes that IRS will implement the tax in a manner that considers the nuances and complexity of the medical device industry. 

In recently submitted comments to the IRS and Treasury, AdvaMed shared its analysis of the influence of regulations for the medical device tax, which is a provision of the Affordable Care Act. “In these comments, we largely focus on our industry as certainly a unique industry to have an excise tax imposed on it with an innovation cycle that is different from other industries that are taxed under this sort of regime,” explained AdvaMed general counsel Andrew Van Haute in a recent press briefing. Namely, the device industry is much more complex, he explained.

The letter also mentions certain uses of devices that would be taxed that are not related to sales. “These are things like the provision of demonstration and evaluation units,” van Haute explained.

AdvaMed’s comments also cited their concerns related to rebates, which are a common form of pricing structure for the device industry.

The letter also urges the IRS to allow flexibility on constructive pricing rules. “These rules are highly complex and do not necessarily align with the types of distribution models and the types of sales that often occur in our industry,” van Haute said.

The retail exception to the tax is another item of listed in AdvaMed's letter to IRS. “We were encouraged by the track that the IRS is taking in not creating a list of exempt devices that will be sold at retail,” he said. “We did suggest a few substantive changes and tweaks to the framework they laid out and we also urged them to really give good guidance to their agents in the field to ensure that the guidance that they put out in the proposed rule doesn’t turn into a checklist and really allows their agents in the field to fully take into account all of the facts and circumstances when deciding whether a device should gain the benefit of a retail exception.” 

A separate letter to IRS from the American Hospital Association, the Federation of American Hospitals, and a number of other healthcare groups expressed their desire to prevent the burden of the tax to be passed on to customers. The letter asked that the tax be implemented “in a manner that recognizes the ‘shared responsibility’ commitment from a broad group of key health care stakeholders, including medical device companies, to bring forward long-needed national health reform through passage of the Patient Protection and Affordable Care Act (‘ACA’).”

IRS will hold a public hearing on May 16 on the device tax. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Social Media Meets Healthcare with Facebook Organ Donor Status

Facebook is the latest Internet giant to debut a feature that could have an impact on healthcare. The company announced May 1 that users of the social networking site can now share their organ donor status via their profiles.

Facebook users can add their organ donor status, including where and when they registered, to Timeline, the site’s chronological user interface. Those who aren’t yet donors can follow a link to sign up with the appropriate registry.

The site also offers other options for sharing health and wellness lifestyle events with followers. There are options to post about overcoming an illness, quitting a habit, weight loss, and more. As with any posts to the site, users can choose to make their health and wellness updates public, private, or viewable only by select Facebook “friends.”

A spokeswoman for the company says Facebook does not intend to expand options for users to share health information via the site.

“We dont have any plans to be in this field beyond the organ donor tool,” the company’s Sarah Feinberg said in a statement.

But people have shown a willingness to share and receive information about their health via social media. A Pricewaterhouse Coopers survey on consumer attitudes and behaviors about social media in healthcare found that almost a quarter of respondents post about their health experiences or updates on social media, and 18% use social media to trace and share their health symptoms or behavior. Almost half say they would use social media to share information about their health with a doctor.

“I think there will be a merging of social media and electronic health records in the future.”

—Steven Waldren, American Academy of Family Physicians’ Center for Health IT

Steven Waldren, MD, director of the American Academy of Family Physicians’ Center for Health IT, says social media is definitely having an impact on healthcare. Patients connect with each other to share information through sites such as PatientsLikeMe, an online health data-sharing platform, and medical devices such as glucometers offer secure online portals for users to upload data about their health. It’s not likely to end there, either.

“I think there will be a merging of social media and electronic health records in the future,” he says. “How that actually looks, it’s way too early to be able to think about that.”

As patients and doctors become more comfortable with integrating social media into healthcare, Waldren posits that social media might play an even more active role in care. Instead of having to check a separate portal, patients may get updates from wireless-enabled medical devices sent directly to the social media sites they check multiple times daily. Diabetic patients, for example, could see their blood sugar levels in their Facebook or Twitter feeds.

“The device could be on the social network,” Waldren says. “The device could actually be tweeting things out.”

If the information were shared, other diabetic patients could respond to offer advice. Alerts could also be built in to notify doctors if the captured data indicates a problem.

But along with opportunities, using social media for healthcare applications presents challenges. For doctors a constant stream of data from patients could create workflow issues. There are also concerns about privacy and HIPPAA compliance.

“It’s just now coming into the healthcare space, which has traditionally had a very specific definition of privacy,” Waldren says. “Social media is going to redefine what patients consider privacy in healthcare.”

Jamie Hartford