Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These data troves can trigger significant compliance responsibilities for the app developer, along with significant legal and contractual risk. This latest installment in our health app series will introduce some of these considerations, including approaches that developers can take to minimize their risk. Continue Reading Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations
Jordan Cohen is an Associate Editor of Health Law & Policy Matters and Associate in the Health Law Practice based in the firm’s New York office. He provides clients with advice and counsel relating to federal health care laws and regulations, including the Stark Law, the Anti-Kickback Law, the Anti-Markup Rule, and state health care laws and regulations. Jordan also counsels clients on compliance with HIPAA’s Privacy Rule and Security Rule, including new requirements under the HITECH Act and 2013 Omnibus Regulations.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 16, 2017. The preview discusses the Administration’s decision to stop paying the cost-sharing reductions (CSRs) that plans have been receiving to cover lower-income individuals under the Affordable Care Act. It also discusses the suit that California and 18 other states and the District of Columbia have filed in response to the Administration’s decision on CSR payments.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 9, 2017. This week’s preview discusses many topics, including the Trump administration’s roll back of the ACA’s mandate that employers cover birth control coverage. It also discusses Congess’ work on health extenders, CHIP, and the community health centers program, among other things. The preview also touches on MedPAC’s recommendation that CMS replace the Merit-based Incentive Payment System (MIPS) which the group believes is too much of a burden on physicians.
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you with a basic understanding of FDA’s evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app’s functionality. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 2, 2017. This week’s preview focuses on the wake left by Secretary Price’s exit, including its impact on the administration’s deregulatory agenda. The preview also discusses Congress’ failure to reauthorize a number of health care programs, including the Children’s Health Insurance Program (CHIP), as well as its failure to address issues related to disproportionate share hospitals (DSH), special needs plans (SNPs) and community health centers.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 18, 2017. This week’s preview focuses on the prognosis for the Graham-Cassidy bill to block grant ACA funding to states, including potential roadblocks imposed by Senators John McCain (AZ), Susan Collins (ME) and Lisa Murkowski (AK). The Weekly Preview also touches on the discord between Senators Lamar Alexander (TN) and Orrin Hatch (UT), who chair the HELP and Finance committees, respectively.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 11, 2017. This week’s preview focuses on Congress’ efforts to stabilize the ACA marketplaces, as well as the proposal from Senators Lindsey Graham (SC) and Bill Cassidy (LA) to use block grants to fund Medicaid expansion and private insurance subsidies.
- How will the health care minibus provisions move?
- Will a market stabilization package come together?
- Will cost-sharing reductions (CSR) payments continue to be made or formally authorized?
- Will ACA “repeal and replace” be resurrected yet again?
This preview is a must read for those seeking to navigate the health care policy landscape in the remaining months of 2017.
Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health. Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests
The U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model. These models were mandatory for hospitals in certain geographic areas. The current administration had delayed the implementation of these models until January 1, 2018. Continue Reading CMS Proposes to Cancel Bundled Payment and Incentive Models