Most Read Contributor in United States, January 2017
As she has done in January for several years, our good friend Marla Durben Hirsch quoted my partner
Elizabeth Litten and me in Medical Practice Compliance
Alert in her article entitled "MIPS, OSHA, other
compliance trends likely to affect you in 2017." For her
article, Marla asked various health law professionals to make
predictions on diverse healthcare matters including HIPAA and
enforcement activities. Full text can be found in the January 2017
issue, but excerpts are included below.
Marla also wrote a companion article in the January 2017 issue
evaluating the results of predictions she published for 2016. The
2016 predictions appeared to be quite accurate in most respects.
However, with the new Trump Administration, we are now embarking on
very uncertain territory in multiple aspects of healthcare
regulation and enforcement. Nevertheless, with some trepidation,
below are some predictions for 2017 by Elizabeth and me taken from
The Federal Trade
Commission's encroachment into privacy and security will come
into question. Litten said, "The new
administration, intent on reducing the federal government's
size and interference with businesses, may want to curb this
expansion of authority and activity. Other agencies' wings may
be clipped." Kline added, "However, the other agencies
may try to push back because they have bulked up to handle this
Telemedicine will run
into compliance issues. As telemedicine becomes more common, more
legal problems will occur. "For instance, the
privacy and the security of the information stored and transmitted
will be questioned," says Litten. "There will also be
heightened concern of how clinicians who engage in telemedicine are
being regulated," adds Kline.
The risks relating to the
Internet of things will increase. "The
proliferation of cyberattacks from hacking, ransomware and denial
of service schemes will not abate in 2017, especially with the
increase of devices that access the Internet, known as the
'Internet of things,' warns Kline. "More devices than
ever will be networked, but providers may not protect them as well
as they do other electronics and may not even realize that some of
them —such as newer HVAC systems, 'smart' televisions
or security cameras that can be controlled remotely — are
also on the Internet and thus vulnerable," adds Litten.
"Those more vulnerable items will then be used to infiltrate
providers' other systems," Kline observes.
More free enterprise may
create opportunities for providers. "For
example, there may not be as much of a commitment to examine
mergers," says Kline. "The government may allow more
gathering and selling of data in favor of business interests over
privacy and security concerns," says Litten.
The ambitious and multi-faceted foray by the Trump
Administration into the world of healthcare among its many
initiatives will make 2017 an interesting and controversial year.
Predictions are always uncertain, but 2017 brings new and daunting
risks to the prognosticators. Nonetheless, when we look back at
2017, perhaps we may be saying, "The more things change, the
more they stay the same."
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
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