Key Findings

The report predicts that mobile health device and service sales will become the main drivers of revenue for the mobile health market in 2012 and in the following years.

According to the report, other factors could contribute to increased mobile health revenue over the next four years, including:

• Advertising on mobile health applications
• Paid downloads
• Transactional revenue

While gathering data for the report—which was sponsored by Intel—researchers reviewed results from an online survey of mobile health decision makers at 50 hospitals in the U.S. as well as Western Europe.

Key Findings

The report found that:

• 42% of all respondents reported that physicians at their organization had high to very high adoption rates for mobile health tools; and
• 86% predicted that physician adoption rates of mobile health tools would rise over the next one to two years.

Respondents reported using an average of 6.4 different mobile devices every day. According to the report:

• 84% of respondents reported using laptops while working
• 56% reported using PC tablet computers; and
• 54% reported using wheeled workstations.

Respondents cited concerns about data security and cost as the two biggest barriers to adopting mobile health tools.

Based on the results from the survey, IDC Health Insights has predicted that spending on mobile health technologies will continue to increase through 2015, driven primarily by software spending, infrastructure upgrades, and data security rather than spending on hardware.

Alarm fatigue refers to the desensitization to audible and visual alarms that caregivers experience when they become overloaded with those alarms from numerous medical devices.

Details of the Letter

 In his letter, Markey made reference to the Boston Globe story from February 2011 that first brought national awareness to alarm fatigue. That story reported that problems with health monitor alarms led to 216 or more deaths in the U.S. between 2005 to 2010.

Markey also cited a separate Globe story from December 2011 that reported that 119 deaths in the U.S. were connected to similar situations involving ventilator alarms since 2005.

Markey wrote that Institute of Medicine should “develop best practice guidelines for device manufacturers and health care providers to protect patient safety and avoid alarm fatigue and other alarm-related safety concerns” (Kowalczyk, “White Coat Notes,” Boston Globe, 12/15).

Markey wrote that these “best practice guidelines” should cover three areas:

• How device manufacturers can help reduce the number of unnecessary alarms and false positives;
• Steps hospitals can take to ensure that caregivers are trained to reduce alarm fatigue; and
• What the FDA (the body that regulates medical device manufacturers) can do to improve adverse event reporting

1. Alarm hazards
2. Exposure hazards from radiation therapy and computed tomography (CT)
3. Medication administration errors using infusion pumps
4. Cross-contamination from flexible endoscopes
5. Inattention to change management for medical device connectivity
6. Enteral feeding misconnections
7. Surgical fires
8. Needlesticks and other sharp injuries
9. Anesthesia hazards due to incomplete pre-use inspection
10. Poor usability of home-use medical devices

It is worth noting that this is the first time alarm hazards have taken the No.1 spot on the list. According to the publication, alarm-related adverse scenarios can occur due to a variety of factors, including:

The FDA’s new guidance defines a “mobile medical app” as a software application on a mobile platform that is “either (1) used as an accessory to a regulated medical device; or (2) transforms a mobile platform into a regulated medical device.” The “mobile medical app” must also meet the qualifications listed in the definition of “device” under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. That definition includes an instrument, apparatus, machine, or a related article that is “intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease for humans or other animals.”

Use of Apps Spreading in Healthcare

Mobile apps are being used increasingly by individuals as tools to help manage personal health and wellness, as well as to help track and manage conditions of diseases. Mobile apps also are being used by many healthcare professionals to aid them in providing medical treatment and care to individual patients. Certain apps, for example, allow users to view radiological images or analyze electrocardiogram data on advanced mobile devices, such as smart phones or tablet computers, to assist patients’ diagnoses.

While the new FDA draft guidance acknowledges that mobile medical apps can provide noteworthy health benefits, mobile apps also may present a number of health risks. In addition, the FDA guidance stresses that the same mobile medical app may pose a variety of differing risks depending on the particular mobile device as well as features including screen size, contrast ratio, and the environmental conditions in which the device is being used (e.g. the kind of lighting in the area).

Purpose of FDA’s Workshop

The FDA’s planned workshop is designed to provide a forum for public discussion on the FDA’s Mobile Medical Application draft guidance document. Specifically, the FDA wants to hear the public’s perspective on how mobile medical apps should be regulated to reasonably ensure their safety and efficacy, particularly mobile medical apps that are accessories to more complex medical devices. The FDA is hoping to host thoughtful discussions on the following key issues:

• What factors should be considered in determining the risk classification of different types of software that provide clinical decision support (“CDS”) functionality?
• How should the FDA assess stand-alone software that provides CDS functionality to guarantee its safety and efficacy?
• Are there specific controls that manufacturers need to implement which may change the risk classification or reduce the premarket data requirements for certain types of stand-alone software that provide CDS functionality?

Anyone who is interested in the topic can visit the FDA website for specific details on how to register for the workshop and/or submit public comments.

“Per Beneficiary” Medicare Spending

Medicare will track hospital efficiency based on “Medicare spending per beneficiary,” equivalent for other measures used for tracking infection rates of surgery patients and mortality rates of heart-attack patients. The intended purpose of the measure is to improve the quality and efficiency of health care by tying Medicare payments to the performance of health-care providers.

In addition to expenses brought on during a patient’s hospitalization, the cost of any medical treatment occurring three days before hospitalization and 90 days after discharge also will be tacked on to the hospitals’ bills for Medicare measurement purposes. Medicare officials claim that using such a long duration should encourage hospitals to coordinate care in an efficient manner over an extended period of time.

Federal officials offered an example of the Medicare spending per beneficiary measurement, which was simplified and republished by The New York Times. In the simplified example, if Medicare spends an average of $9,125 per Medicare beneficiary at one hospital, and the comparable cost at every U.S. hospital is $12,467, the single hospital would receive a higher score for efficiency.

This efficiency score would then be combined with scores from other measures to create an overall performance score for that hospital. Medicare will then use the overall performance scores to determine a higher or lower percentage to be paid for each claim the hospital files. This system, known as value-based purchasing, rewards and distributes more funds to higher-performing hospitals. Full details of the measure are still being finalized, but Medicare began computing performance scores in July 2011 and plans to implement the value-based purchasing system by October 2012.

Concerns Rise Over the Quality of Patient Care

Unsurprisingly, many hospital administrators dislike the notion of being held accountable for expenses arising from care beyond the walls of their facilities. They say they have very little influence over medical treatment occurring after a patient has been discharged and essentially no control over the treatment a patient receives before being admitted.

Additionally, teaching hospitals may earn lower efficiency scores and be penalized by the value-based purchasing system because they often treat patients with more severe conditions, which adds to the cost of treatment. Medicare officials claim that efficiency data will be adjusted to consider factors such as patients’ ages and the severity of their illnesses. Regardless, president of the Greater New York Hospital Association, Kenneth E. Raske, says the efficiency measure “tends to discriminate against inner-city hospitals with large numbers of immigrant, poor and uninsured patients.”

Many in medical community have agreed that paying hospitals based on performance is important, but implementing the right measures of performance is crucial. President of the Federation of American Hospitals, Charles N. Kahn III, says officials are “off track” in holding hospitals responsible for what Medicare ends up spending on patients nearly three months after discharge.

Further, numerous hospital administrators and patient-safety advocates are concerned about the long-term ramifications of a measure that emphasizes low costs rather than quality outcomes, especially in regards to patient safety. For example, the focus on lower costs could result in fewer diagnostic tests being ordered and performed, potentially leading to missed or incorrect diagnoses. Especially in cases where early detection and quick treatment are vital to recovery, such cost-cutting measures could put the very life of a patient at stake.

EHRs and related health IT have been marketed as tools to enhance patient safety, but the promise remains largely unfulfilled at the present time, wrote co-authors Ryan P. Radecki, MD, department of emergency medicine, East Carolina University Brody School of Medicine, in Greenville, N.C., and Dean F. Sittig, PhD, professor at The University of Texas Health Science Center at Houston (UTHealth) School of Biomedical Informatics, in their commentary titled “Application of Electronic Health Records to the Joint Commission’s 2011 National Patient Safety Goals.”

The authors offered the following example: EHRs with CDS interventions integrated into CPOE have been shown to improve clinicians’ performance on process metrics, yet their effect on patient outcomes has yet to be seen.

Joint Commission Pushing EHR Adoption

The Joint Commission’s National Patient Safety Goals for 2011 include correctly identifying patients, delivering test results more quickly and accurately, ensuring that medications are labeled correctly, examining medications for potential adverse reactions, preventing and reducing infections, and identifying patients who may be at risk of suicide.

Improving the rate at which EHRs can be used to address patient safety issues would involve implementing the National Patient Safety Goals into the existing criteria for EHR certification.

The authors stated, “The 2011 National Patient Safety Goals provide high-yield guidance to EHR certification and oversight bodies who should refine their criteria for meaningful use to include incentives for development and use of tools to enhance safety. As with all computer-based interventions, incorporation of EHRs into routine clinical workflow is critical; their effectiveness depends on appropriate maintenance, effective user training, periodic institutional self-assessment of EHR safety and effectiveness, and clinically focused policies to support their use.”

They concluded, “Although EHRs by no means represent all necessary mechanisms to address critical safety problems, they can provide tools to help organizations improve their performance.”

According to the New York Times, the fourth-leading cause of death in the United States is hospital-acquired infections (nosocomial infections). Nosocomial infections are infections, such as pneumonia, that patients contract while receiving treatment in hospitals. These infections cost the U.S. healthcare system over $40 billion every year.

Hospitals across the nation are taking steps to decrease the prevalence of nosocomial infections, making incredible progress in some areas. Yet, studies show there is still a long way to go.

Safety Checklists Prove Effective

An experiment conducted in 2003 in Michigan demonstrated the effectiveness of a simple checklist in reducing certain types of patient infections. To reduce the occurrence of central-line catheter infections, the Michigan Health and Hospital Association required 103 intensive-care units to use a five-point checklist when inserting catheters into patients. The results were incredible: the median rate of infection dropped to zero and remained at zero throughout 15 months of follow-up monitoring.

The same hospitals implemented a similar checklist method to reduce ventilator-associated pneumonia. Again, by using the checklist method, the hospitals were successful in eliminating this infection, reducing the median infection rate to zero.

Risks of Hospital-Acquired Infections

Despite the success of checklists in reducing hospital-acquired infections, there is still great room for improvement. One of the main causes of nosocomial infections is the hospital workers’ failure to wash their hands frequently enough. A study published in the American Journal of Medicine Quality revealed that most hospitals have hand-washing rates below 50 percent. The study also showed that medical personnel in intensive care units only wash their hands one quarter as often as they should.

Atul Gawande, author of The Checklist Manifesto, says implementing checklist systems in more hospitals nationwide will help improve rates of basic tasks such as hand washing. He says hospital checklists work well for several key reasons. First, lists are reminders to busy hospital personnel who may overlook a step in a routine procedure when doing many things at once. Second, lists instill a sense of responsibility among the people involved in performing a procedure; everyone is responsible for the success or failure of the procedure. Each person has the right and the duty to say something if someone is skipping a step on the checklist.

The information was collected through a research survey conducted in November 2010 by Stratton Research. There were 418 responses to the survey, which was sent to more than 2,500 hospital biomedical technicians and clinical engineers. The results were published in the March/April 2011 issue of the Biomedical Instrumentation & Technology. Clinical engineers and hospital professionals discussed the findings at the recent AAMI conference held on June 27.

The top 10 biomedical challenges were:

1. Interfacing between devices and information systems
2. Maintaining computerized IT systems
3. Managing alarms
4. Maintaining and processing endoscopes
5. Broken connectors
6. Wireless management
7. Battery management
8. Problems with patient monitors
9. Problems with dialysis equipment
10. Managing the radiation dose from CT

“In terms of solutions to these challenges, clinical engineering veterans and other professionals hit the same broad themes: better education and training, stronger and communication and cooperation among departments, and often a need for standards,” stated Paul W. Kelley, CBET, of Washington Hospital Healthcare System in Fremont, Calif.

“The successful implementation of interoperability requires defined objectives and measurable goals”, noted Carol Davis-Smith, CCE, Premier Healthcare Alliance in Charlotte, N.C., “as well as a complete and well-maintained physical inventory of the applicable items included in the network.” Davis-Smith recommended prioritizing and making data-driven decisions when implementing interoperable devices.

“What we’re finding out there in the community, is that one, our basic CMO mass inventory is not clean. We need to get that cleaned up, and the reason being, because we need to have IT collect this really granular data about each of those individual devices, what can talk and what cannot talk, to what extent does it talk and how does it talk,” Davis-Smith said. “Bringing this level of granularity might be an ice-breaker in the IT department.”

Kelley said, “We learned [from the survey] that IT plays a huge role in biomedical engineering, as three of the top 10 challenges are IT-related. The IT department, clinical engineers, clinicians and vendors have to work together. Healthcare is most definitely a team sport.”

Related to interoperability, alarm management was also a strong focus of Monday’s discussion. Managing alarms has become a widespread issue—gaining media exposure with stories in The Boston Globe, The Washington Post, CBS Nightly News, and National Public Radio—as hospitals are attempting to manage the alarm fatigue caused by the countless visual and audible alarms directed at nurses each day.

“In terms of the top 10 medical device challenges, it really interacts with so many of the other challenges: interfacing, computer updates, broken connectors, patient monitors,” said J. Tobey Clark, CCE, of the University of Vermont in Burlington. “All of those other hazards directly impact clinical alarms.”

Clark said that sounds are actually just a portion of the problem. He said caregivers cannot recognize more than six different alarm sounds and have difficulty distinguishing between high- and low-priority alarms.

“This clinical alarm problem is very complex,” he said. “The stumbling block is human limitations. Because it’s a complex problem, you need a complex solution,” Clark said. “We need a multi-disciplinary approach to resolve this problem. False alarms and nuisance alarms [are] by far the biggest problems that lead to alarm fatigue.”

The issue of clinical alarm fatigue will be the focus of an upcoming AAMI summit in Herndon, Virginia, Oct. 4-5.

This makes authorized accreditors very important for EHR certification programs because healthcare providers will be relying upon EHR certification bodies to help meet meaningful use requirements.

The rule proposed by the ONC explains both the conduct violations and the possible consequences that could be levied against authorized accreditors and details the ONC’s process for disciplining poor performers, including the possibility of replacement due to conduct violations.

Under the ONC’s permanent certification program, which will be implemented on January 1, 2012, the accreditor must ensure that the authorized certification bodies follow reliable methods of surveillance of vendor products. According to the proposed provisions, conduct violations include fraud, withholding or altering information that would indicate fraud, falsifying accreditations of certifying organizations, and failure to perform in a satisfactory manner.

The ONC will be able to assess the accreditor’s performance through the annual reports made by the certifying organizations which will detail EHR product surveillance. The surveillance results will include feedback from the accreditor as well.

The permanent program will make EHR certification more thorough and reliable than the temporary processes currently used to approve EHRs. Temporary testing and certification will cease on December 31, 2011.

“We believe that a removal process would protect the integrity of the permanent certification program and maintain public confidence in the program,” the ONC said in the proposed rule, which was published in the May 31 Federal Register. The proposed rule is open to public comments until August 1.