Supply Chain Integrity and Security

The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.

An Oxford on-line dictionary definition of integrity is “the state of being whole and undivided”. Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges – and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes.

The solution is not an easy one. It requires urgent action to mitigate activities of the ‘bad guys’, together with a longer term approach to ensure the ‘good guys’ get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start?

We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more ‘process’ orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session.

Then we must turn attention to the building of supply chains for the future – the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA’s 21st Century Modernization initiative and ICH Q8 – 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth.

Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

Areas Covered in the Session:

• How to organize for supply chain integrity throughout the product life cycle
• Current approaches to clamping down on criminal activity in the supply chain
• Issues causing greatest concern to regulators and how to address them
• Role of ICH Q8 – 11 in building robust supply chains
• How the disciplines of procurement and supply chain management (SCM) can be leveraged
• Role of technology as an enabler

Who Will Benefit:

• Research chemistry and biochemistry
• Chemical and biochemical engineering
• Chemistry, manufacturing, and controls
• Preclinical Development
• Clinical Development
• Regulatory Affairs
• Quality Assurance

Speaker Profile

Hedley Rees is a practicing consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.

Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey.

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Seminar on HIPAA 2019 | HIPAA Security Risk Assessment | What’s new?

Description:

This two-day seminar will get into the fine details of what we need to do and how to do it.

We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Why you Should attend:

Join me in this two day seminar to explore what’s new with HIPAA both from a regulation standpoint (new requirements) and an enforcement standpoint

Omnibus has changed the HIPAA landscape for good!

Do you know all of the requirements of this enigmatic law?

Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task… Times have changed and new laws are now in place concerning protected health information. The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive

This once rarely enforced law has changed and you need to know what’s going on!

Protect your practice or business!

 

Areas Covered in the Session:

Study all 18 Standards and 44 Implementation Specifications of the regulations

Updates for 2019

Requirements of Compliance Officers

New definition of what constitutes protected health information

Real life litigated cases

BYOD

Portable devices

Business associates and the increased burden

Emailing of PHI

Texting of PHI

Federal Audit Process

HIPAA and suing – how this works

Risk Assessment

Who Will Benefit:

Practice managers

Any business associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc)

MD’s and other medical professionals

Agenda:

Day 1 Schedule

Lecture 1:

HIPAA a Brief History

Lecture 2:

HIPAA Privacy vs Security

Lecture 3:

New definition of what constitutes protected health information

Lecture 4:

HIPAA and the Business Associate

Lecture 5:

Through examination of all 18 Standards and 44 Implementation Specifications of the HIPAA Security Rule and how to apply them

Lecture 6:

How to enforce policy for each standard and implementation specification

Lecture 7:

HIPAA and litigation

Day 2 Schedule

Lecture 1:

The Federal Audit Process and things to be ready for

Lecture 2:

HIPAA and Suing – how this works and examples of real cases

Lecture 3:

Technology and HIPAA – best practices and big “no-no’s”

Lecture 4:

Ransomware, Viruses, bad technology

Lecture 5:

HIPAA Texting and Emailing – myth vs reality

Lecture 6:

Personal Devices and HIPAA

Lecture 7:

HIPAA and the Audit Process

Lecture 8:

How to conduct a HIPAA Security Risk Assessment

Speaker:

Brian L Tuttle

ex-FDA Expert and former Associate Center Director of CDRH

Brian L Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 18 years’ experience in Health IT and Compliance Consulting.

With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 18 years’ experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.

Location: Miami, FL Date: April 18th & 19th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  Hyatt Place Miami Airport East, 3549 NW 42nd Ave, Miami, FL 33142, USA

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 10, Early Bird Price: $2,000.00, From March 11 to April 16, Regular Price: $2,200.00

Sponsorship Program benefits for seminar

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globalcompliancepanel@gmail.com

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Virtual Seminar on HIPAA Training for Compliance Officer

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do’s and don’ts with HIPAA -I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations

I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!

In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).

Why you should attend

Join me in this in depth 6-hour seminar where we will get into the nitty-gritty about the roles and responsibilities of a HIPAA Compliance Officer.

Do you have an affective HIPAA compliance program? Do you know what needs to be done to satisfy the requirements?

New laws, funding, and enforcement mean increased risk for both business associates and covered entities – 2017 was a record year for enforcement and fines – 2018 will be no different.

HIPAA Omnibus – Do you know what’s involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Court cases that are changing the landscape of HIPAA and patient’s ability to sue!

TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.

Who Will Benefit

• Practice Managers
• Any Business Associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc)
• MD’s and other medical Professionals

Agenda

• Updates for 2019
• Requirements of Compliance Officers
• New definition of what constitutes protected health information
• Real life litigated cases
• BYOD
• Portable Devices
• Business associates and the increased burden
• Emailing of PHI
• Texting of PHI
• Federal Audit Process
• HIPAA and suing – how this works
• Risk Assessment
• Ransomware and how to avoid
• What to do when a breach occurs
• Best Resources

Speaker Profile

Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). Almost all of Brian’s clients are earned by referral with little or no advertising. Brian is well known and highly regarded in medical circles throughout the United States .

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A to Z’s of HIPAA Privacy, Security, and Breach Notification Rules

It is designed to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance by covered entities and business associates.

It provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Benefits from this Rules:

• Information Security Officers
• Risk Managers
• Compliance Officers
• Privacy Officers
• Health Information Managers
• Information Technology Managers
• Medical Office Managers
• Chief Financial Officers
• Systems Managers
• Legal Counsel
• Operations Directors

HIPAA Privacy Rule Principles, Policies and Procedures

• Patient Rights under HIPAA
• Limitations on Uses and Disclosures
• Required Policies and Procedures
• Training and Documentation Requirements

Recent and Proposed Changes to the HIPAA Rules

• New Penalty Structure
• New HIPAA Audit Program
• New Patient Rights
• New Obligations for Business Associates

Go through here for detailed rules

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we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Internal Audit Checklist for HIPAA

The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.

The Department of Health and Human Services (HHS) is tasked with monitoring the compliance aspect of the law, i.e., it monitors how medical organizations comply with the provisions of HIPAA. In order to ensure that medical organization stay compliant with the provisions of HIPAA; auditors measure these compliance aspects with a checklist when testing companies’ medical data recording processes.

The internal audit checklist for HIPAA, like any other checklist, is a list of do’s and don’ts that a healthcare organization has to look to see if it is complying with its processes relating to medical data sharing and recording. These are the core areas against which auditors prepare and monitor the internal audit checklist for HIPAA:

Analysis and assessment of risk

One of the foremost aspects of the internal audit checklist for HIPAA is the organization’s analysis and assessment of the risk involved in disclosing medical information. Medical organizations of the designated types have to carry these out at regular, periodic intervals in ensuring that they don’t give opportunities for causing data breaches. Since healthcare organizations are involved in collecting, keeping and transferring of medical information; it is necessary for them to keep analyzing and assessing the risk involved in data breaches.

Gap analysis

In this category of internal audit checklist for HIPAA; auditors compare regulatory guidelines to security systems in the corporate sector. The idea is to help the medical organization outline its security requirements vis-a-vis its security infrastructure

Remediation

In this internal audit checklist for HIPAA; the healthcare organization relies on a number of technologies and steps to prevent any breach of data, and to also offset the damage done when a breach happens. The primary tools used in this internal audit checklist for HIPAA include software used for tracking defects, for process reengineering, CRM and a few ERP applications.

Planning for contingencies

An internal audit checklist for HIPAA also includes a set of plans that the healthcare organization has to have to be able to plan for contingencies. A healthcare organization can expect emergencies or disasters from any source, and these can be of any kind. An internal audit checklist for HIPAA should include plans for anticipating and dealing with these.

Personnel policies

The policy a healthcare organization puts in place for its personnel is an important point in the internal audit checklist for HIPAA. It has to decide what kinds of trainings its staff members receive for implementing HIPAA compliance.

 

 

 

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Las Vegas hospitals must follow regular HIPAA privacy rule

After natural disasters, HHS sometimes waives certain HIPAA privacy rule requirements. That’s not usually the case after man-made disasters, such as Sunday night’s massacre in Las Vegas, where more than 50 were killed and hundreds were wounded after a gunman opened fire at a music festival.

Because the HIPAA privacy rule already allows information disclosure in certain cases, such as when public safety is threatened, and because there has been no declaration of a public health emergency, HIPAA waivers have not been necessary in this case.

Local hospitals will have to be careful, especially with so many requests for information from families, friends, and the media, said Mark Swearingen, a Hall Render attorney focused on health information privacy and security.

“Hospitals are going to have to be very careful about vetting and authenticating the individuals who might be calling in to make sure that they’re the type of person they can be sharing information with,” he said.

After Hurricane Harvey struck Texas in August, HHS Secretary Dr. Tom Price waived certain HIPAA penalties, which can range from $100 to $50,000 per violation. Providers would not be penalized for failing to giving out notices of privacy practices, for instance, nor would they be hit for not granting a patient the right to request privacy restrictions.

Meanwhile, other provisions of the HIPAA privacy rule were still in effect, including those that allow providers to disclose protected health information to patients’ families or others involved in their care. Other provisions allow providers to give out protected health information—including to law enforcement—if doing so would lessen a threat to those patients or to the public.

Given those rules, “when you have a shooting, the department has taken the position that a waiver isn’t necessary,” said Marcy Wilder, a privacy and cybersecurity lawyer with Hogan and Lovells, noting that no penalties were waived after the 2016 mass shooting that killed 49 people and injured 58 at Orlando’s Pulse nightclub. “The department wants to be careful here, because if you issue a waiver, that becomes a suggestion that without a waiver, these types of disclosures aren’t permitted,” she added.

Swearingen warns that Las Vegas hospitals therefore need to be cautious. “The hospital, I would hope, in this circumstance is going to be fairly guarded.”

Read More: http://snip.ly/8u7xj#http://www.modernhealthcare.com/article/20171002/NEWS/171009996/las-vegas-hospitals-must-follow-regular-hipaa-privacy-rule

 

What should Entities do to avoid HIPAA fines and penalties?

A look at the nature and numbers of HIPAA breaches over just the couple of years makes stark reading: On the one hand, in terms of numbers; 2016, with about 16 million records breached was a pretty good year compared to the previous year, in which about seven times that number, more than 113 million, were breached. But the bad news is that 2016 saw more Covered Entities reporting breaches than in any other year since the Office of Civil Rights (OCR) started publishing its data on healthcare record breaches.

These huge numbers show that not only is there a big demand for these records in the black market -they are in greater demand than even social security and credit cards -Covered Entities and Business Associates need to all that it takes to avoid HIPAA fines and penalties.

The federal government has not been lax on this aspect. It is being extremely vigilant about protecting healthcare records. It has been consistently urging the HHS to take a serious view of the increased incidence of cyberattacks that has resulted in medical records theft and has suggested many measures towards ensuring this. The fact that there has been a steady increase in the global spending on cybersecurity-related hardware, software, and services and could reach $100 billion in 2020, according to estimates by the International Data Corporation (IDC), suggests the seriousness with which this issue is being viewed not just in the US, but all over the world.

One of the primary requirements that Business Associates need to comply with is adherence to HIPAA mandates regarding the handling and use of health information. This is spelt out in the HITECH Act, a recent update made to overall HIPAA regulations. It is mandatory for a Business Associate to comply with a wide range of regulatory obligations, which include certain privacy obligations, security standards, and breach notification requirements.

However, there is a lot of confusion and misunderstanding among Business Associates about their roles and requirements. They must be completely knowledgeable about all the aspects of their roles, functions and requirements before they enter into agreements of contracts with subcontractors and vendors for their services

Learning about ways of avoiding HIPAA fines and penalties

Jay Hodes, who is President and Founder, Colington Security Consulting, LLC, will be providing thorough understanding of the roles and requirements of a Business Associate and Covered Entities in HIPAA enforcement at a webinar that is being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry. Please visit What should Entities do to avoid HIPAA fines and penalties? to get complete clarity of the ways of avoiding HIPAA fines and penalties.

Clarity on how to avoid HIPAA fines and penalties

The aim of this learning session is to help businesses understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure that their current compliance program is adequate and can withstand government scrutiny.

Jay will highlight the importance of being compliant with the HIPAA requirements for an organization if it has to avoid HIPAA fines and penalties. The ways by which a Business Associate or Covered Entity can provide the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI) and what all it has to have in place for doing so, will all be explained.

He will cover the following areas at this session:

• Why was HIPAA created?
• Who Must Comply with HIPAA Requirements?
• What are the HIPAA Security and Privacy Rules?
• What are the Consequences of being a Business Associate
• What is a HIPAA Compliance Program for a Business Associate?
• What is a HIPAA Risk Management Plan?
• What is a HIPAA Risk Assessment?
• What is the Role of the HIPAA Security Official?
• What are HIPAA training requirements?
• What is a HIPAA data breach and what happens if it occurs?
• What are the penalties and fines for non-compliance and how to avoid them
• Case Examples of HIPAA Data Breaches
• Creating a Culture of Compliance
• Q&A.

 

 

Hurricane Harvey HIPAA Reminder

Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct categories (e.g., covered entity, business associate, and subcontractor), other state or federal government entities use “covered entity” to mean any person that creates, receives, maintains or transmits PHI or PII.

HIPAA sets forth three main categories of safeguards: administrative, physical, and technical safeguards. Often times, these categories overlap. For example, the administrative requirement of a sanction policy compliments the physical requirement of two-factor identification for building access.

Below are a couple of select sections from the Code of Federal Regulations (CFR), which organizations should be particularly vigilant about in relation to disasters.

•45 CFR §164.310 (Physical) – requires that policies and procedures for facility access in order to restore lost data under the disaster recovery and emergency access plan.

•45 CFR §164.308 (Administrative Safeguards) – multiple requirements are set forth under this particular section of the CFR. For example:

•Security management process

•Annual risk analysis

•Information activity review

•Workforce clearance procedure

•Security awareness training

•Contingency plan

 

Read More: http://snip.ly/duepz#http://www.diagnosticimaging.com/blog/hurricane-harvey-hipaa-reminder

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

The Value and Importance of Health Information Privacy

Ethical health research and privacy protections both provide valuable benefits to society. Health research is vital to improving human health and health care. Protecting patients involved in research from harm and preserving their rights is essential to ethical research. The primary justification for protecting personal privacy is to protect the interests of individuals. In contrast, the primary justification for collecting personally identifiable health information for health research is to benefit society. But it is important to stress that privacy also has value at the societal level, because it permits complex activities, including research and public health activities to be carried out in ways that protect individuals’ dignity. At the same time, health research can benefit individuals, for example, when it facilitates access to new therapies, improved diagnostics, and more effective ways to prevent illness and deliver care.

The intent of this chapter¹ is to define privacy and to delineate its importance to individuals and society as a whole. The value and importance of health research will be addressed in Chapter 3.

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CONCEPTS AND VALUE OF PRIVACY

Definitions

Privacy has deep historical roots (reviewed by Pritts, 2008; Westin, 1967), but because of its complexity, privacy has proven difficult to define and has been the subject of extensive, and often heated, debate by philosophers, sociologists, and legal scholars. The term “privacy” is used frequently, yet there is no universally accepted definition of the term, and confusion persists over the meaning, value, and scope of the concept of privacy. At its core, privacy is experienced on a personal level and often means different things to different people (reviewed by Lowrance, 1997; Pritts, 2008). In modern society, the term is used to denote different, but overlapping, concepts such as the right to bodily integrity or to be free from intrusive searches or surveillance. The concept of privacy is also context specific, and acquires a different meaning depending on the stated reasons for the information being gathered, the intentions of the parties involved, as well as the politics, convention and cultural expectations (Nissenbaum, 2004; NRC, 2007b).

Our report, and the Privacy Rule itself, are concerned with health informational privacy. In the context of personal information, concepts of privacy are closely intertwined with those of confidentiality and security. However, although privacy is often used interchangeably with the terms “confidentiality” and “security,” they have distinct meanings.Privacy addresses the question of who has access to personal information and under what conditions. Privacy is concerned with the collection, storage, and use of personal information, and examines whether data can be collected in the first place, as well as the justifications, if any, under which data collected for one purpose can be used for another (secondary)² purpose. An important issue in privacy analysis is whether the individual has authorized particular uses of his or her personal information (Westin, 1967).

Confidentiality safeguards information that is gathered in the context of an intimate relationship. It addresses the issue of how to keep information exchanged in that relationship from being disclosed to third parties (Westin, 1976). Confidentiality, for example, prevents physicians from disclosing information shared with them by a patient in the course of a physician–patient relationship. Unauthorized or inadvertent disclosures of data gained as part of an intimate relationship are breaches of confidentiality (Gostin and Hodge, 2002; NBAC, 2001).

 

Read More: http://snip.ly/tlhw0#https://www.ncbi.nlm.nih.gov/books/NBK9579/