Building on attempts in recent years to strengthen the Department of Justice’s (DOJ’s) white collar criminal enforcement, on September 15, 2022, Deputy Attorney General Lisa Monaco announced revisions to DOJ’s corporate criminal enforcement policies. The new policies, and those that are in development, further attempt to put pressure on companies to implement effective compliance policies and to self-report if there are problems. Notably, the new DOJ policies set forth changes to existing DOJ policies through a “combination of carrots and sticks – with a mix of incentives and deterrence,” with the goal of “giving general counsels and chief compliance officers the tools they need to make a business case for responsible corporate behavior” through seven key areas:
DOJ Further Revises Corporate Criminal Enforcement Policies: Focusing on Individual Accountability, Corporate Responsibility, and Additional Demands on Chief Compliance Officers
Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters, recalls, and inspections. But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains. FDA has what is now a massive data set on Medical Device Reports (or “MDRs”) that can be mined for quality data. Medical device companies can, in effect, learn from the experiences of their competitors about what types of things can go wrong with medical devices.
The problem, of course, is that the interesting data in MDRs is in what a data scientist would call unstructured data, in this case English language text describing a product problem, where the information or insights cannot be easily extracted given the sheer volume of the reports. In calendar year 2021, for example, FDA received almost 2 million MDRs. It just isn’t feasible for a human to read all of them.
In this episode of the Diagnosing Health Care Podcast: While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up.
What can businesses do to prevent or mitigate potential civil and criminal charges in this area?
Podcast: Owner’s Outlook: HCA’s Clint Russell on Health Care Construction Pricing and Innovation – Diagnosing Health Care
In this episode of the Diagnosing Health Care Podcast: Since the beginning of 2022, prices for construction services and materials have seen significant increases. How have these increases impacted the advancement of both new and ongoing health care construction projects?
On this episode of our Owner’s Outlook series, hear from special guest Clint Russell, Vice President of Capital Deployment – Construction and Equipment at HCA Healthcare.
No More Exceptions: What to Do When the California Privacy Exemptions for Employee, Applicant and B2B Data Expire
The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) gives consumers increasingly more control over their personal information when collected by businesses subject to the law. We have previously discussed the compliance requirements of these data privacy laws on organizations doing business in California. Significantly, CCPA/CPRA defines the term “consumer” to mean any California resident; which from a business perspective, such a broad definition encompasses not only the business’s individual customers, but also its employees, job-applicants or even business-to-business (B2B) contacts. With the moratoriums currently in place for B2B and employee/applicant data sunsetting on January 1, 2023 and not likely to be extended, and the prospect for federal data privacy legislation with wide preemptive effect of state law looking less likely, businesses should be actively preparing to meet these expanded statutory obligations.
A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter investments in the companies doing the importing. Turns out, the agency was not. The FDA’s recent activities in the region were well within their historical norms.
But the project got us thinking, what does the agency’s enormous database on import actions tell us about the agency’s enforcement priorities more generally? There are literally thousands of ways to slice and dice the import data set for insights, but we picked just one as an example. We wanted to assess, globally, over the last 20 years, in which therapeutic areas has FDA been enforcing the 510(k) requirement most often?
Podcast: Owner’s Outlook: Maximize and Safeguard Reimbursement Through Design – Diagnosing Health Care
Now on the Diagnosing Health Care Podcast: The COVID-19 pandemic kicked off a pivot in health care construction and design, and acute care facilities have been rapidly renovating to adapt their spaces to evolving public health care needs.
On August 16, 2022, in Williams v. Kincaid, the Fourth Circuit held that gender dysphoria can qualify as a disability under the Americans with Disabilities Act (the “ADA”). This is the first federal appellate decision which extends the ADA’s protections to transgender people experiencing gender dysphoria and it will have a significant impact on all entities covered by the ADA, including employers (covered by Title I of the ADA), and public accommodations (covered by Title III of the ADA). Prior to this holding, several of the district courts have come down both ways on the issue.
From the Diagnosing Health Care Podcast: How have complaints of information blocking been submitted to the Office of the National Coordinator (ONC), and by whom? What does government enforcement action really look like?
In this episode of our special series on interoperability, hear from ONC attorneys Cassie Weaver and Rachel Nelson.
On August 19, 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 22-16 (“AO 22-16”) to its website, a favorable opinion concluding that the OIG would not impose sanctions in connection with a program that offered $25 gift cards to Medicare Advantage (“MA”) plan enrollees who completed an online educational program about the potential risk, benefits, and expectations related to surgery. AO 22-16 is the latest in a string of recent OIG advisory opinions addressing arrangements involving remuneration to Federal health care program beneficiaries – the ninth such advisory opinion in 2022 alone.