Although the incorporation of technology into human endeavours—commercial, political and personal—is a normal component of technological innovation, the advent of artificial intelligence technology is producing significant challenges we have not felt or understood with earlier innovations. For many years, for example, there has been speculation, research and public debate about the impact of the internet, the functioning of search engines, and online advertising techniques on commercial and political decisions.

The alleged “hacking” of the 2016 US presidential election, and the concerns about such activities in the 2017 European elections, will only heighten the interweaving discussions on free speech, national sovereignty, cyber security and the nature of privacy.

The use of artificial intelligence and machine-learning technologies has only added to the list of issues and areas of concern. The consequences of automobile accidents involving “self-driving” technologies, the “flash crashes” on securities markets due to algorithmic trading, and bias in systems designed to determine benefit eligibility, are requiring us to consider what happens when we defer judgment to machines, and highlighting the importance of quality in data sets and sensors.

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The Enhanced Nurse Licensure Compact (Compact) has now been adopted by 26 states, which means the Compact will be taking effect on January 19, 2018. Nurses who seek to practice telemedicine and deliver in-person care across state lines and who meet the Compact’s licensure requirements in these states will have one less obstacle to overcome going forward.

The Compact is an updated version of the original compact allows for registered nurses (RNs) and licensed practical/vocational nurses (LPN/VNs) to have one multistate license, which will enable them to practice nursing in person or via technology (e.g., videconference) in both their home state, as well as the other Compact states. Development and implementation of the Compact was not an easy feat, given the need for alignment of licensing standards across the Compact states, including federal and state fingerprint-based criminal background checks.

The 26 states participating in the Compact as of today are Arizona, Arkansas, Delaware, Florida, Georgia, Idaho, Iowa, Kentucky, Maine, Maryland, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming.

For more information about the Compact, please visit: https://www.ncsbn.org/11070.htm.

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

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Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Continue Reading FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems. Continue Reading Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and Human Services (OIG) describing inappropriate payments to physicians under the program. The report follows on the heels of a high-profile settlement under the False Claims Act between the US Department of Justice and an EHR vendor related to certified electronic health record technology (CEHRT) used in the EHR Incentive Program (which we’ve previously discussed in-depth).

The OIG reviewed payments to 100 eligible professionals (EPs) who received EHR incentive payments between May 2011 and June 2014 and identified 14 inappropriate payments. OIG extrapolated the results of the review to the 250,470 total EPs who received incentive payments during that time period and estimated that CMS made approximately $729 million in inappropriate EHR incentive payments out of a total of just over $6 billion in such payments during the review period. Continue Reading OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments

As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology.  Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18.  The bill was signed into law by Governor Abbott last weekend.

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On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with a focus on patients who are at risk for cardiac arrhythmias.

In January 2012, the remote monitoring company reported that a workforce member’s laptop containing the ePHI of over a thousand individuals was stolen from a parked vehicle outside of the employee’s home. A little over one year later, the same company reported a second breach that compromised the ePHI of twice as many individuals (details regarding this breach were not provided by OCR).

OCR’s investigation revealed that the company allegedly had insufficient risk analysis and risk management processes in place at the time of the theft. Additionally, the company’s draft policies and procedures implementing the standards of the HIPAA Security Rule had never been implemented, and the company was also unable to produce final versions of any policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices.

Continue Reading Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation.

The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) to test the effect of including telehealth services in Medicare health care delivery reform models. More specifically, the Act would require CMMI to assess telehealth models for effectiveness, cost and quality improvement, and if the telehealth model meets these criteria, then the model will be covered through the Medicare program. Continue Reading More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims.

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