The fast-growing field of digital health is transforming healthcare by bringing together digital communications technology, electronic health information, electronic prescribing, connected medical devices, and telehealth. These technologies are being deployed by healthcare entities ranging from small health tech startups to large, established hospital systems, medical device companies, and other traditional healthcare companies. Telehealth systems are already in use for applications as varied as direct-to-consumer urgent care and remote provider-to-provider consultations for treatment of complex conditions such as strokes or rare genetic diseases. With these exciting new developments comes a new set of regulatory challenges and concerns for companies in the space. This alert provides a brief overview of some of the laws and regulations that may apply to health companies engaging in digital health.
- Opens application process and public comment period for precertification pilot program
- Nine companies to be chosen by September 1, 2017
Last June, FDA Commissioner Scott Gottlieb made his first public statement as Commissioner by announcing the imminent rollout of a new “Digital Health Innovation Plan.” This statement signaled his intent to prioritize the agency’s efforts to create – and clearly articulate – a regulatory regime that promises to “help innovators navigate a new, modern regulatory process” that will efficiently enable the delivery of safe and effective digital health technologies to patients and consumers.
On July 28, FDA formally rolled out its Digital Health Innovation Action Plan, along with a process for companies to apply to participate in one key component: the Software Precertification Pilot Program. The Action Plan describes several concrete deliverables that the agency plans to complete by the first quarter of 2018 to put a “reimagined” regulatory regime for digital health technologies in place. This will include:
Senate Republicans have released several bills in recent weeks in support of their goal of repealing and replacing the Affordable Care Act (ACA). This morning, that effort appears to have failed.
On Tuesday, the Senate narrowly approved a motion to proceed, allowing the chamber to begin consideration of measures to achieve that goal. Republican Senators Susan Collins of Maine and Lisa Murkowski of Alaska voted with the Democrats against the motion, but Vice President Mike Pence broke the resulting 50-50 tie. That vote allowed debate to move forward on a range of healthcare legislative options.
The next step for proponents of the repeal effort was to agree on what, if anything, would replace the ACA. Three options were considered, and all were voted down:
Senate Republicans have released several bills in recent weeks in support of their goal of repealing and replacing the Affordable Care Act (“ACA”). This afternoon, the Senate narrowly approved a procedural step that allows the chamber to begin consideration of measures to achieve that goal. Republican Senators Susan Collins of Maine and Lisa Murkowski of Alaska voted with the Democrats against the motion to proceed and Vice President Mike Pence broke the resulting 50-50 tie.
Today’s vote allows debate to move forward on a range of healthcare legislative options. The next step for proponents of the repeal effort is to agree on what, if anything, will replace the ACA. It remains to be seen if any of the legislative proposals (including straight repeal with no immediate proposal to replace) put forward so far will be able to draw enough votes to pass the closely divided Senate. One possibility may be a “skinny repeal” bill limited to repealing the individual mandate, employer mandate, and medical device tax. If passed, this bill could be approved by the House as-is, but would more likely move to conference with the House.
The Office for Civil Rights within the U.S. Department of Health and Human Services (OCR) has taken its first enforcement action against a business associate. On June 30, 2016, OCR announced that it entered into a resolution agreement and corrective action plan with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) to settle potential HIPAA violations stemming from the theft of an employee’s company-issued cell phone that contained the particularly sensitive protected health information (PHI) of 412 nursing home residents. CHCS is a nonprofit organization that, at the time of the theft, provided management and information technology services to six nursing homes in the Philadelphia region, in addition to its other services for the benefit of the elderly, developmentally disabled individuals, young adults aging out of foster care, and individuals living with HIV/AIDS. As part of the settlement, CHCS is required to pay a resolution amount of $650,000. This announcement comes nearly three years after OCR was vested with direct enforcement authority over business associates.
On Thursday, June 22, 2017, Senate Republican leaders released their legislative proposal to amend the Affordable Care Act (ACA). A revised version of the bill was released on June 26. The Senate’s take on healthcare legislation, titled the Better Care Reconciliation Act of 2017 (BCRA), comes after the House passed the American Health Care Act (AHCA) by a narrow margin in early May. The Senate bill is structurally similar to the House version, but it departs from the AHCA in important ways. The Senate bill makes deeper cuts to Medicaid and establishes a different set of subsidies to help individuals purchase insurance. The BCRA is labeled a “discussion draft,” but Senate leaders have set an ambitious goal of holding a vote on the measure before the July 4th holiday.
Key provisions of the BCRA are outlined below.
Repealing and replacing the Affordable Care Act (ACA) has long been a priority of congressional Republicans, yet recent events in Washington suggest that accomplishing this goal will be harder than originally anticipated. In early May, the House of Representatives narrowly passed the American Health Care Act of 2017 (AHCA). The AHCA rolled back a host of ACA provisions, including the individual and employer mandates and numerous taxes funding the expansion of healthcare coverage. The Congressional Budget Office (CBO) projected that enactment of the bill would result in cutting over $830 billion from Medicaid and 23 million people losing coverage by 2026. Rather than embrace the AHCA, Senate Republicans crafted their own bill, the Better Care Reconciliation Act of 2017 (BCRA). Similarly, it would effectively eliminate the mandates and numerous taxes associated with the ACA. Notably, however, it differs in its approach to Medicaid. The CBO projected that enactment of the BCRA would remove $772 billion from Medicaid and would increase the number of uninsured Americans by 22 million by 2026. The Senate scheduled a vote on the BCRA prior to Congress’s July 4 recess, but it was ultimately cancelled by Republican leadership because of a lack of votes.
On Thursday, May 4, 2017, the U.S. House of Representatives narrowly passed the American Health Care Act (AHCA) by a vote of 217 to 213. The AHCA as passed includes recent amendments offered by Representatives MacArthur and Upton. The key provisions that impact every individual, healthcare provider, healthcare insurance carrier, and employer sponsoring a group health plan are explained below. Continue Reading House Passes the American Health Care Act—What You Need to Know
One of President Trump’s first official actions was to sign an executive order affirming the administration’s intent to seek repeal of the Affordable Care Act (ACA) and directing federal agencies to minimize the economic and regulatory burdens of the ACA to the fullest extent permitted by law. While Congress and the White House continue to work out the specifics of a new healthcare policy, the administration has moved its repeal effort forward in important ways. Continue Reading Congress Continues to Consider Its Affordable Care Act Repeal and Replacement Options While the Trump Administration Moves Forward with Regulatory Action