Administrative Agency Health Privacy

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OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

NIST Internet Of Things Framework Taking Shape

The National Institute of Standards and Technology (“NIST”) recently posted a preliminary discussion draft of its forthcoming Framework for Cyber-Physical Systems (a term used interchangeably with the Internet of Things, or...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

Today the Food and Drug Administration (FDA) published a notice announcing the availability of a draft guidance document entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The...more

UK Information Commissioner’s Office (ICO) Receives Power to Audit National Health Service

The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

Survey Says Sharing Information is Crucial in a Volatile Data Security Environment

Information sharing allows for better insight into existing threats and vulnerabilities and alerts organizations to the existence of important data that can help prevent cyberattacks and mitigate the effects of ongoing...more

Obama Administration the Target of Hackers; Former Administration Official Recipient of Subpoena Related to Cybersecurity

The Obama Administration's handling of cyber and data security was recently brought into question due to two distinct security incidents. On the same day that a former Administration official received a subpoena related to...more

Blog: FDA Cybersecurity Workshop for Healthcare

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

FDA Flunks Data Security Exam

Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Medical Staff Bylaws: Compliance Gaps and Best Practices - Part 1

In this presentation: - Background - Definitions - Purposes/Preamble - Nature of Medical Staff Membership - Qualifications for Membership - Insurance...more

Health Headlines: Also in the News - September 2014 #3

Congressman Sends Letter to Secretary of HHS Urging Her to Retract CMS’s Global Settlement Offer – On September 15, 2014, Congressman Kevin Brady (R-Tex), Chairman of the House Ways and Means Health Subcommittee, sent a...more

OIG Finds Privacy and Security Risks with ONC EHR Certification Process

It is ironic to learn the Office of Inspector General (OIG) believes the Office of the National Coordinator for Health Information Technology (ONC) essentially has an insufficient compliance program to maintain the privacy...more

Enforcement Action – FTC Is Not Backing Down and Laboratory Company Goes After a Cyber-Intelligence Company

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is not the only government arm that enforces data breaches. The Federal Trade Commission (FTC) has broad authority to regulate the security of...more

Counties Beware – Your Governmental Status Does Not Protect You from Liability for a HIPAA Breach

As a county government, you may think that you have the protection of sovereign immunity and protection from other governments penalizing you. Your status does not protect you. The Department of Health and Human Services...more

HHS Issues Policy Regarding Physician FOIA Requests

On January 17, 2014, the Department of Health and Human Services (HHS) published its “Modified Policy on Freedom of Information Act Disclosure of Amounts Paid to Individual Physicians Under the Medicare Program” (the Modified...more

HHS Issues Privacy Rule Guidance for Law Enforcement Agencies

The Office for Civil Rights (OCR) of the Department of Health and Human Services recently announced the release of its guidance, “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: A Guide for Law...more

HIPAA Omnibus Final Rule - What's in it for Patients?

The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a...more

HIPAA Omnibus Rule - Google+ Hangout

For a first look at the HIPAA omnibus rule, I had a Google+ Hangout on Air with Brian Ahier and Deven McGraw. We talked through the changes made to the privacy and security rules, the breach notification rule, the enforcement...more

Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement

The final regulations from Department of Health and Human Services Office of Civil Rights (OCR) containing modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (Omnibus Rule) have finally...more

Health Law Blog: Final HIPAA Rules Released

Yesterday, the U.S. Department of Health and Human Services (HHS) released the long-awaited final rules implementing changes to the HIPAA privacy and security rules enacted in 2009 by the HITECH Act....more

The HIPAA/HITECH Final Rule Has Been Released

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

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