Mark Lutes, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Meaningful Use, Federal Regulation Top Priorities for Health IT in 2012."
Following is an excerpt:
Due to both the delay in Stage 2 and the difficulties experienced by providers attempting to meet meaningful use of EHRs, a ''continued easing of the compliance bar [for meaningful use],'' should be expected in 2012, said Lutes.
Lutes said he expects the mobile device community and others with interest in mobile health technologies—including health care providers, patient advocacy groups, and health plans—to work with FDA to identify which mobile health applications pose ''sufficient risk to justify regulatory scrutiny.''
''I also expect that the provider community with a track record of successful customization of clinical software will want dialogue with FDA over where it might concentrate its review so as not to be needlessly in conflict with health information technology goals while advancing patient safety,'' Lutes added.
''To-date, most attention has been focused on data security,'' Lutes said. ''It is my view that the consumer-patient harm of data security breaches is often overstated while the risks to patients from lack of data integrity are frequently underappreciated.''
Reproduced with permission from Health IT Law & Industry Report, 4 HITR 15, 01/09/2012.
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