Bipartisan Health Information Technology Improvement Bill Passes Senate Committee
On February 9, the Senate Committee on Health, Education, Labor and Pensions unanimously passed the Improving Health Information Technology Act (S. 2511). The goal of the bill, as described by Committee Chairman Lamar Alexander (R-TN), “is to make our country’s electronic health record system something that helps patients rather than something that doctors and hospitals dread so much that patients are not helped
. . . .” Among other provisions, the legislation would permit nonphysicians, such as nurses, to document on behalf of physicians; confer upon the Department of Health and Human Services Office of Inspector General the authority to investigate and establish deterrents to information-blocking practices that interfere with the sharing of electronic health information; and ask the Governmental Accountability Office to review mechanisms for securely matching patient records to the correct patient. The bill would also create a rating system permitting users to share feedback regarding health information products and helping providers select the best technology for their practices and facilities.
Lawmakers Seek Guidance from HHS on Mobile Health Apps
Responding to concerns of health care providers regarding the interplay between new health information technologies and privacy laws, a bipartisan group of lawmakers sent a letter to HHS on March 10 requesting clarification of the impact of privacy laws on mobile health applications. The lawmakers noted commitments made by HHS in 2014 with respect to clarifying standards for HIPAA compliance, cloud storage of health data, and regular engagement with technology companies, and expressed frustration regarding the lack of progress by the agency.
The HHS Office for Civil Rights (OCR), which is charged with monitoring the protection and security of health information, did provide some guidance in February of this year. OCR noted that app developers with direct provider relationships are deemed business associates subject to HIPAA rules because they contract for patient management services. On the other hand, app developers whose products are selected by consumers directly, and are not recommended for purchase by providers, likely would not be subject to HIPAA business associate obligations.
The lawmakers noted in their letter, though, that the “lack of clarity around HIPAA applicability in a mobile environment prevents many patients from benefiting from” technology and that many physicians “are reluctant to receive information from their patients electronically without clear regulatory guidance.” The letter further stated that “HHS has failed to provide even the simplest guidance to explain whether physicians and patients can text each other.” This situation appears to be a prime example of technologies outpacing the agencies charged with regulating them.
MEDTECH and Regulations in the Medical Software Industry
Counsel for the CDS Coalition on March 10 reiterated its request for more clarity on regulations governing the industry. Clinical decision support (CDS) software is a classification of technologies ranging from software that communicates with implanted devices to tools that help providers with prescription decisions and automated alerts. The most recent request came in response to the Senate Health, Education, Labor and Pensions Committee’s support of the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act at a committee hearing on March 9. The MEDTECH legislation would strip the FDA of its authority to monitor certain technologies, including CDS software and electronic health records. While CDS software is generally considered low risk and does not require pre-approval from the FDA before going to market, the CDS Coalition counsel noted that the agency has been promising to develop CDS software guidance since 2011 and the lack of any progress since then has led to the delay and abandonment of many projects.
The majority of the CDS software affected by MEDTECH is low risk since CDS software primarily provides doctors with tools for sorting and finding relevant information in patient records. However, MEDTECH would not exempt CDS software that is capable of permitting doctors to confirm the software’s recommendation. While the MEDTECH Act appears to ease the regulatory burden on some CDS software, the CDS Coalition notes that the lack of a clear and consistent regulatory framework has generated innovation-stifling uncertainty among developers and investors.