The Final Rule amending 42 CFR Part 2 finalizes changes that will align uses and disclosures of Part 2 information with HIPAA for treatment, payment & health care operations. Part 2 providers and others who must comply with Part 2 and this Final Rule have two (2) years to get into compliance. Read more about the changes and how we can help with compliance.
Genetic testing companies, and those who partner with them, must take care to ensure that the scope of how consumers’ sensitive data is used and shared in the future aligns with the scope of consent that was granted by the consumer at the point of collection. The FTC found that a California-based genetic testing company informed consumers that it would only share consumers’ sensitive health and other personal information “in limited circumstances,” but then expanded sharing such information with new third parties, like supermarket chains. The FTC has now stepped up to protect consumers’ sensitive genetic information.
The New Year is finally here, and I believe that there will be a LOT going on in 2023! Here are just a few of the things that Legal HIE is looking to stay on top of for our readers this year . . .
As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a updated running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list):
On May 1, modifications to the Medicare Conditions of Participation (“CoPs”) went into effect, requiring certain electronic event notifications for admissions, discharges and transfers (“ADTs”) to and from hospitals, critical access hospitals and psychiatric hospitals. To provide guidance to hospitals and state surveyors, CMS released several FAQs as well as interpretive guidance last week to be published in the State Operations Manual.
Hospitals are required to make a “reasonable effort” to ensure that notifications are sent to post-acute care services providers and suppliers, and other practitioners and entities, which need such notifications for treatment, care coordination or quality improvement. Under the new CoP, ADT notifications must be sent for all emergency department and inpatient patients where the hospital, critical access hospital or psychiatric hospital maintains an electronic medical record or administrative system.
The Court of Appeals for the Fifth Circuit vacated the $4.3M penalty imposed on M.D. Anderson as arbitrary, capricious and contrary to law.
Interim Final Rule with Comment Period Responds to COVID-19 Pandemic. Responding to public health threats posed by the coronavirus pandemic, today the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) released an interim final rule with comment period that extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements.
At the last hour, CMS extended the deadline for publishing much anticipated changes to the Stark Law. Originally expected for publication this past August, CMS extended the deadline to August 2021, noting that “… we are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date.” Together with the OIG’s counterpart rule, the proposed rules contain the potential for significant modernization of the Stark Law and Anti-kickback Statute as part of the “Regulatory Spring to Coordinated Care” as well as increased alignment and coordination between the two sets of laws.
The extended deadline for hospitals to submit their hardship applications for the Medicare Promoting Interoperability Program is approaching. Hospitals have until September 1 to file for a hardship for the 2019 reporting period and avoid negative payment adjustments in 2021.
On July 16, the Court of Justice of the European Union (“CJEU”) invalidated the Privacy Shield, one of the primary mechanisms used by companies to lawfully transfer personal data outside of the European Union under the GDPR. Despite a prior adequacy determination in 2016, the CJEU found that shortcomings in the Privacy Shield, particularly U.S. security and surveillance laws and an ineffective Ombudsperson program, resulted in a failure to provide essentially equivalent protections to those afforded to individuals within the European Union.
Under the Privacy Exception, an Actor is permitted to not fulfill a request received to access, exchange, or use EHI to protect an individual’s privacy. The sub-exception for a “precondition-not-satisfied” will continue to put state laws governing privacy and consent at the center of decisions about whether EHI will be shared with third parties. Healthcare providers and HIEs/HINs especially will need to ensure that they have identified and analyzed each legal precondition to the release of EHI that is applicable to the particular type of entity and type of information that is implicated.
As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list): [updated: July, 28, 2021]
Proposed Rules Extend EHR Donation Sunsets for Stark and Anti-Kickback Earlier this month, CMS and OIG proposed amendments to and extension of the temporary Stark exception and Anti-kickback safe harbor for electronic health record (EHR) donations to physicians. The Proposed EHR Rules...
HHS Partners with Private Sector to Combat Healthcare Fraud On Thursday, July 26, the Department of Health and Human Services (HHS) announced a new partnership between the public and private sectors to stomp out healthcare fraud. With HHS funding, federal, state and private...
We “Like” Organ Donor Status on Facebook This post has been prepared by Christina Strong, Esq. The addition of “organ donor status” to Facebook is a tremendous boon for the communication of what is fast becoming a social norm, altruistic donation of one’s body, to take place after death. Unlike...