Regulation of Mobile Healthcare and its Impact on Convergence in the US • • •
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virtually all physicians will be using smartphones by 2013, while virtually all patients and families will use at least a cell phone;
virtually all physicians will use tablets as a companion to the smartphone by 2015; right now, 40 % of physicians use tablets;
the number of US inpatient monitored beds will increase from 290,000 to one million by 2015;
home monitoring is a $9.3 billion market; and the mHealth applications (‘apps’) market will reach $1.7 billion by 2015.
However, mobility for mobility’s sake will not help organizations achieve greater goals.
Meaningful Mobility
‘Meaningful mobility’ refers to native mobile technology that improves clinical decision-making at the point of care through data transformation, and insures the secure, real time, ubiquitous delivery of visually compelling intelligence by incorporating evidence-based medicine and knowledge-based prompts. Meaningful mobile computing optimizes patient throughput and access to care, transcends geographic barriers, expedites provider workflow logistics, and guides better choices by patients and providers.
An example of this are new communication technologies that transmit expanded digital electrocardiograms (ECGs) directly to a smartphone or mobile device, allow rapid viewing of ECGs by experts, and can be used to overcome logistical and geographic barriers to care. Thanks to added data for analysis, touch screen manipulation, and visual clarity, providers may be able to interpret ECG findings more accurately. Combined with simultaneous access to historical ECGs, these advances allow cardiologists to be better informed and to intervene earlier in the time-sensitive process of cardiac evaluation and treatment, thereby leading to better outcomes for patients, providers, and hospitals.
Organizing an effective response to cardiac emergencies requires immediate mobilization across multiple departments or organizations, timely communication among providers12
, and careful coordination to ensure optimum resource management and outcomes.
The best way to ensure a timely and accurate diagnosis is to get the ECG to all the clinicians involved in the diagnosis and treatment of the patient immediately. Having the right data in the right hands at the right time makes all the difference.13
Timely and accurate diagnosis of myocardial infarction (MI) can reduce the time to treatment,14
reduce false positive activations of the cardiac
catheterization team, improve patient outcomes, reduce the long-term costs of cardiac care, and improve public health by minimizing damage during the acute phase of illness.
For the early evaluation and triage of patients with ST elevation myocardial infarction (STEMI), a fully automated, field-based, wireless network that transmits ECGs automatically to offsite cardiologists via a mobile device, compared with current methods of ECG captured at the time of arrival at the emergency department, shortens door-to-balloon (D2B) times (63 minutes versus 119 minutes), reduces infarct size, limits
iHEALTH CONNECTIONS
ejection fraction reduction (50 % versus 35 %), and shortens hospital length of stay (3 days versus 5.5 days),15 by $10,000 per case.16
and has reduced hospital costs
Mobile technology will play a crucial role in the development of new care models that can improve the quality of care, reduce costs, prevent job losses, generate revenue, and create more healthcare jobs.17 However, it is important that hospitals and providers understand the evolving regulatory environment specific to mobile technology before making an investment.
Hospitals Must Stay Apprised of Mobile Regulatory Developments
The rule says that anyone who creates or significantly modifies an MDDS is considered a ‘manufacturer’, and must adopt a quality system.
In February 2011, the FDA and the Department of Health and Human Services (HHS) issued a final rule regulating medical device data system (MDDS) products, which transfer, store, convert, or display medical data.18
Providers should know that, under this new rule, any hospital that creates or significantly modifies an MDDS is considered a ‘manufacturer’ and is therefore subject to regulation and inspection. The risks associated with MDDS potentially include inaccurate, incomplete, or untimely data transfer, as well as storage, conversion, or display of medical data that might lead to incorrect patient diagnosis or treatment. Based on an evaluation of these risks, the FDA has determined that general controls such as the Quality System Regulation (21 CFR part 820) will provide a reasonable assurance of safety and effectiveness.
‘Manufacturers’ must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMPs).
In July 2011, the FDA and HHS published a draft guidance regarding mobile medical applications for the industry and FDA staff.19
From
their perspective, a mobile application—or ‘mobile app’—is a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.
Hospitals can effectively deal with FDA regulation for MDDS and mobile technology by working with vendors that deliver apps and products that are 510K cleared. (510K is the mechanism through which medical devices are allowed by the FDA to be marketed in the US.)
Summary
To achieve effective healthcare reform and restrain the growth in costs, we must strike a balance between improving the efficiency of healthcare delivery, and aligning financial incentives to reward more effective and efficient care.
In response to a growing demand and a shrinking workforce in transition, hospitals and health systems must increasingly rely on technology to
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