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New Rule Challenges Hospitals, Not Vendors, to Make EHRs Safer

New Rule Challenges Hospitals, Not Vendors, to Make EHRs Safer
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Alston & Bird Health Care Week in Review - April 2021 #5 | Alston & Bird

Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS released its FY 2022 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Rates Proposed Rule. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On April 26, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) f ....

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CMS proposes modifications to the Promoting Interoperability Program

Electronic Reportable Laboratory Result Reporting.
Requiring hospitals to report these four measures would help to prepare public health agencies to respond to future health threats and a long-term COVID-19 recovery by strengthening public health functions, including early warning surveillance, case surveillance and vaccine uptake, which will increase the information available to help hospitals better serve their patients, said CMS officials.
The new requirements would enable nationwide syndromic surveillance that could help provide early notices of emerging disease outbreaks, according to CMS.
Additionally, automated case and lab reporting would speed response times for public health agencies, while broader and more granular visibility into immunization uptake patterns would help these agencies tailor their vaccine distribution plans. ....

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OCR Issues Proposed Modifications to HIPAA Privacy Rule to Remove Barriers to Coordination of Care and Reduce Regulatory Burden | McDermott Will & Emery

OVERVIEW
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) adopted under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act (collectively, HIPAA). The proposed modifications support individuals’ engagement in their care, remove barriers to coordinated care and reduce regulatory burdens in the health care industry under HHS’s Regulatory Sprint to Coordinated Care.
IN DEPTH
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) adopted under th ....

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OCR Issues Proposed Modifications to HIPAA

Individual Right of Access
The NPRM would make several changes to individuals’ Privacy Rule right to inspect and obtain copies of their protected health information (PHI) maintained in a designated record set. The proposed changes would:
Expand the methods that individuals may use when inspecting their health information to include the ability to take notes, videos and photographs.
Require covered entity health care providers to allow patients to review PHI upon request that is readily available at the point of care in conjunction with a health care appointment.
Reduce the time limit for covered entities to provide access from 30 to 15 calendar days. ....

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